The present disclosure relates to an apparatus and process for forming medical devices from an injectable composition. The apparatus includes a supply assembly configured to maintain and selective dispense a first precursor and a second precursor, a mixing assembly configured to mix the first and second precursors, and at least one catalyzing element including a transition metal ion to aid in the polymerization of the first and second precursors. The process includes dispensing a volume of the first precursor and a volume of the second precursor into a mixing assembly and mixing the first and second precursors. The first and second precursors each possess a core and at least one functional group known to have click reactivity with each other. The mixed precursors are contacted with a transition metal catalyst to produce a flowable composition for use as a medical device.

A method for securing an implantable medical device onto a balloon which includes applying a coating, which includes a film-forming polymer and at least one solvent, to the outer surface of the balloon. The solvents can include alcohol, water, ether and combinations thereof. The film-forming polymer can include a zwitterionic polymer, such as, for example a phosphorylcholine polymer. The coating can be applied to the entire balloon surface or a portion of the surface. The implantable medical device is then positioned on the outer surface of the balloon and secured. The film-forming polymer is then allowed to cure in order to define an adhesive layer between an inner surface of the implantable medical device and the outer surface of the balloon. This method prevents or reduces the leaching or redistribution of any therapeutic agents dispersed within or on the surface of the implantable medical device.

A medical device used in a medical robotic system has a conduit and an orientable tip. An optical fiber coupled to a laser source and/or a catheter coupled to one or more biomaterial sources extends through the conduit and tip so that the tip of the medical device may be robotically directed towards a target tissue for laser and/or biomaterial application as part of a medical procedure performed at a surgical site within a patient. A protective sheath covers the fiber as it extends through the conduit and tip. A first coupler adjustably secures at least the sheath to the medical device and a second coupler adjustably secures the fiber to at least the sheath. A similar dual coupler mechanism may be used to secure the sheathed catheter to the medical device.

An attachment for a surgical instrument including a drive input hub for connection to a power source; a drive output hub for connection to a surgical instrument; and a body connecting the drive input hub to the drive output hub, the body including a mechanism for transferring drive from the input hub to the output hub, and wherein the body, the drive input hub and the drive output hub are at least in part not coaxial. A method for surgically preparing a bone using the attachment is also provided.

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

A test strip ejector system for receiving and ejecting a fluid testing medical device test strip includes a mechanism assembly supported by the device whereby user actuation of the mechanism assembly induces displacement of the test strip in at least a test strip ejection direction to eject the test strip. The mechanism assembly includes a power source and an electric motor such as a piezo-electric linear micro motor connected to the power source. The electric motor has an armature displaced when the electric motor is energized. A digital display/user interface is provided. Selection of an ejection function presented on the digital display/user interface initiates operation of the electric motor and displacement of the armature thereby displacing the test strip in the ejection direction. An operating system including a microprocessor is connected to the display/user interface. The microprocessor controls direction of operation and operating speed of the motor.

The present invention provides an assembly for the preparation of a medical device having a porous coating comprising hydrogen peroxide. Particularly interesting medical devices are catheters (such as urinary catheters), endoscopes, laryngoscopes, tubes for feeding, tubes for drainage, guide wires, condoms, urisheaths, barrier coatings e.g. for gloves, stents and other implants, extra corporeal blood conduits, membranes e.g. for dialysis, blood filters, devices for circulatory assistance, dressings for wound care, and ostomy bags. The coating is in particular a hydrophilic coating formed from cross-linked polyvinylpyrrolidone. In one embodiment, the assembly holds a dry catheter element in one compartment of a package and an aqueous hydrogen peroxide solution in another compartment. The solution may also comprise stabilizers, e.g. chelators, and osmolality increasing agents. The catheter for insertion in the urethra is useful for the treatment, alleviation or prophylaxis of microbial infections such as urinary tract infections (UTI).

Methods of reclaiming plastic from plastic medical waste containers containing medical waste and manufacturing recycled medical devices are described. Recycled medical devices made from plastic medical waste containers containing medical waste are also described.

A pump system (120) has a central pump unit (110), with which at least one hook-up unit (130). The least one hook-up unit (130) is from a group of a plurality of hook-up units (130) that can be combined in modular form for setting an operating point of a pump (10) that forms the pump unit (110). A method uses such a hook-up unit (130) in a pump system (120) for setting an operating point of the pump unit (110) thereof. A medical device is provided with such a pump unit (110) or with such a pump unit (110) and at least one hook-up unit (130) combined with the pump unit (110).

A light-based medical diagnostic system includes a plurality of semiconductor diodes with pump beams and a multiplexer capable of combining the pump beams and generating at least a multiplexed pump beam comprising one or more wavelengths. A first waveguide structure is configured to receive at least a portion of the one or more wavelengths and outputs a first optical beam. A second waveguide structure is configured to receive at least a portion of the first optical beam and to communicate at least the portion of the first optical beam to an output end of the second waveguide structure to form an output beam. A lens system is configured to receive at least a portion of the output beam and to communicate at least the portion of the output beam onto a part of a patient's body, such as a patient's blood.

Medical devices, methods and kits are described. An exemplary medical device comprises a catheter that has a catheter wall and defines a catheter lumen, a bend, and a coil disposed distal to the bend. The catheter defines one or more apertures that extend through the catheter wall and are in communication with the catheter lumen.

A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

Pressure sensing guidewires are disclosed. The pressure sensing guidewires may include a tubular member having a proximal portion and a distal portion. The distal portion may have a plurality of slots formed therein. The distal portion may have a first wall thickness along a first region and a second wall thickness smaller than the first wall thickness along a second region. A pressure sensor may be disposed within the distal portion of the tubular member and housed within the second region. An anti-thrombogenic coating may be disposed on an inner surface, an outer surface, or both of the second region of the distal portion of the tubular member.

Karen gives an update on the advocacy of software freedom for medical devices, while Bradley continually takes the show off-topic.

Show Notes:

• Bradley mentioned Jimmy Fallon's … And We're Back script.
• Barnaby Jack showed lethal attacks exist on wireless devices. (06:25)
• Karen previously gave a talk about her heart condition on the show. (07:13)
• Hugo Campos, who also works on this issue. (26:08)
• Bradley mentioned the Therac-25 software-related disaster. (29:30)

Send feedback and comments on the cast to <oggcast@faif.us>. You can keep in touch with Free as in Freedom on our IRC channel, #faif on irc.freenode.net, and by following Conservancy on on Twitter and and FaiF on Twitter.

Free as in Freedom is produced by Dan Lynch of danlynch.org. Theme music written and performed by Mike Tarantino with Charlie Paxson on drums.

The content of this audcast, and the accompanying show notes and music are licensed under the Creative Commons Attribution-Share-Alike 4.0 license (CC BY-SA 4.0).

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

As manufacturers - including companies such as automakers that do not typically produce healthcare devices - race to help fill medical equipment shortages during the COVID-19 crisis, steps must be taken to ensure adequate security testing, says Fairuz Rafique of cybersecurity services firm EmberSec.

While medical professionals everywhere around the globe are working as hard as they can, both them as well as consumers are trying to get protective products to remain healthy and, where possible, prevent being contaminated. It is clear that in seve...

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Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.

Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, the online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.

“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division.

Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged today with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators.

Guidant LLC pleaded guilty today in St. Paul, Minn., before U.S. District Court Judge Donovan W. Frank to criminal violations of the Federal Food, Drug and Cosmetic Act.

Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was formally convicted and sentenced today in St. Paul, Minn., for criminal violations relating to its interactions with the Food and Drug Administration (FDA).

Smith & Nephew Inc. has entered into a deferred prosecution agreement with the Department of Justice to resolve improper payments by the company and certain affiliates in violation of the Foreign Corrupt Practices Act (FCPA).

Biomet Inc. has entered into a deferred prosecution agreement with the Department of Justice to resolve improper payments by the company and its subsidiaries in violation of the Foreign Corrupt Practices Act.

Orthofix Inc., a Texas-based manufacturer of medical devices, has agreed to pay the United States $34,234,263 to settle allegations under the civil False Claims Act relating to the company’s sale of bone growth stimulator devices, the Justice Department announced today. The company has also agreed to plead guilty to a felony of obstruction of a federal audit, and to pay a $7,765,737 criminal fine.

ArthroCare Corporation, a medical device manufacturer based in Austin, Texas, and that trades on the NASDAQ stock exchange, has agreed to pay a $30 million monetary penalty to resolve charges that senior executives at the company engaged in a securities fraud scheme that resulted in more than $400 million in shareholder losses.

Medical device manufacturer EndoGastric Solutions Inc. has agreed to pay the government up to $5.25 million to resolve allegations that it violated the False Claims Act by misleading health care providers about how to bill federal health care programs for a procedure using a device manufactured by the company and by paying kickbacks.

Ashvin Desai, of San Jose, California, was sentenced yesterday to serve six months in prison and six months and one day of home confinement for concealing more than $8 million in foreign bank accounts, the Justice Department and Internal Revenue Service (IRS) announced. Prior to yesterday’s sentencing hearing, Desai filed with the court a document indicating that the IRS has assessed and demanded payment of a Reports of Foreign Bank and Financial Accounts (FBAR) penalty against him for $14,229,744

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn

Vascular Solutions Inc. (VSI) has agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial, the Justice Department announced today

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?