BATU KAWAN: US-based medical devices company Dexcom Inc has officially opened its manufacturing facility, also its first offshore manufacturing site outside the United States, in Batu Kawan, Penang.

Penang Chief Minister Chow Kon Yeow said the RM2.83 billion strategic investment will bring more than 3,000 jobs to the state, contributing to a workforce set to positively impact the lives of over three million people worldwide.

Dexcom, founded in 1999, is a global leader in continuous glucose Monitoring (CGM) technology for individuals living with diabetes.

“The establishment of this new facility highlights Dexcom’s continued commitment to take control of health through innovative CGM systems. It also reaffirms Penang’s reputation as a global hub for advanced technological industries, reinforcing its position as a preferred destination for high-quality manufacturing and innovation,” the chief minister said in his speech at the opening ceremony here today.

Chow said Penang is on the right path towards becoming the medical technology (medtech) hub of Southeast Asia by leveraging on the state’s over 50 years of industry excellence.

“Housing the largest number of medtech companies nationally and regionally, Penang remains a highly attractive location for its infrastructure availability and ecosystem that meet the needs of the medtech industry.

“For the past five years (2019-2023), Penang garnered a total of RM5.8 billion worth of investments in the scientific and measuring equipment sector, representing 45% of the nation’s total investments in this sector, involving 33 projects and generating an estimated 4,630 employment opportunities,” he said.

Dubbed the Silicon Valley of the East, Penang has the highest concentration of medical technology companies in Malaysia and Southeast Asia to date. – Bernama

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SOLIDWORKS Helps Companies Automate Documentation, Analysis, and Data Management for Compliance

The analysis of extractables and leachables and subsequent risk assessment is an important aspect of the determination of biocompatibility for many medical devices. Leachable chemicals have the potential to pose a toxicological risk to patients, and therefore it is required that they be adequately characterized and assessed for potential safety concerns. One important consideration in the assessment of leachables is the choice of a suitable simulating solvent intended to replicate the use condition for the device and its biological environment. This aspect of study design is especially difficult for blood-contacting medical devices due to the complexity of simulating the biological matrix. This publication reports a comparison of the extracting power of different binary solvent mixtures and saline in comparison with whole blood for a bloodline tubing set connected to a hemodialyzer. Ten different known extractables, spanning a range of physicochemical properties and molecular weights, were quantified. The results indicated that for low-molecular-weight analytes, a suitable exaggeration for whole blood can be obtained using a low-concentration ethanol/water mixture (20%), and in general, extracted quantity increases with the concentration of alcohol cosolvent. For polyvinylpyrrolidone, the opposite trend was observed, as solubility of the polymer was found to decrease with increasing alcohol concentration, resulting in lower extracted quantities at high alcohol concentrations. Analysis of ethanol/water concentrations in the extract solutions post extraction indicated no change in solvent composition.

In an effort to strengthen the regulatory activities for medical devices in the country, the Union health ministry has framed and finalised rules regulating the method of recruitment to various posts under the Central

The Department of Pharmaceuticals (DoP) has released the operational guidelines for the newly announced central sector scheme for Strengthening of Medical Device Industry (SMDI), aiming at providing

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After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

The medical devices industry in India is experiencing remarkable growth, with 2023 revenues reaching approximately (and) #8377;1,04,760 crores (US (Dollor) 12.8 billion).

The Health Ministry has notified the Medical Devices Rule, 2017 in which manufacturers of medical devices will be required to meet risk proportionate regulatory requirements.

The government's new Rs 500 crore scheme for the medical device industry will not only boost domestic manufacturing but also reduce reliance on import, said medtech leaders on Saturday.

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The Corporate Whistleblower Center is urging an employee of a drug or medical device company to call them anytime if they can prove their employer is concealing harmful or deadly side effects because this kind of information could be worth millions.

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The South Africa medical device market will register a 9.1% CAGR between 2017-2018 according to a recent Fitch Solutions report. This significant growth will raise the market to USD 1.27 bn by 2018.

The Corporate Whistleblower Center is urging an employee of a medical device or drug company to call them anytime at 866-714-6466 if they possess proof their employer is selling consumers defective or dangerous products-Don't Get Mad-get rewarded!

The Corporate Whistleblower Center says, "If you work for a medical device/products company and your employer's product is defective-please call us at 866-714-6466 and hopefully get rewarded for what you know-and be a hero for consumers."

Medical devices comprising an anti-connexin agent suitable for introduction into a subject.

An intracorporeal autonomous active medical device having a capsule body and a base. The capsule body includes a body portion and a lid portion, and the capsule body contains therein electronic circuitry containing the active elements of the autonomous medical device, and a power supply. The capsule body also includes a fastening system on an exterior surface of the capsule body that is configured to correspond with a fastening mechanism on the base configured to be anchored to a tissue wall. The fastening mechanism provides selective engagement between the capsule body and the base.

An implantable medical device (IMD) can include a cardiac pacemaker or an implantable cardioverter-defibrillator (ICD). Various portions of the IMD, such as a device body, a lead body, or a lead tip, can be provided to reduce or dissipate a current and heat induced by various external environmental factors. According to various embodiments, features can be incorporated into the lead body, the lead tip, or the IMD body to reduce the creation of an induced current, or dissipate the induced Current and heat created due to an induced current in the lead. For example, an IMD can include at least one outer conductive member and a first electrode. The first electrode can be in electrical communication with the at least one outer conductive member. The first electrode can dissipate a current induced in the at least one outer conductive member via a first portion of the anatomical structure.

Implantable devices and related systems utilize power management features in conjunction with a recharge circuit that includes a coil and capacitance. The reactance such as the capacitance and/or inductance may be variable such that in the event of an overcharge condition, the reactance may be varied to change the resonant frequency of the circuit of the coil from the recharge frequency to another frequency to reduce the power being received. Other power management features may additionally or alternatively be employed. For instance, the device may send an uplink telemetry signal to an external device to request that recharge power be decreased. The device may switch additional resistance into the circuit of the coil to reduce the Q of the circuit. As another example, the device may clamp the circuit of the coil to ground.

A medical device, comprising first and second components coupled via a first wireless link; and a third component coupled to the first device via a second wireless link. The device implements a communication scheme in which transmissions via the second wireless link occur during a time period that is interleaved between periods including transmissions via the first link.

An improved implantable pulse generator (IPG) containing improved telemetry circuitry is disclosed. The IPG includes charging and telemetry coils within the IPG case, which increases their mutual inductance and potential to interfere with each other; particularly problematic is interference to the telemetry coil caused by the charging coil. To combat this, improved telemetry circuitry includes decoupling circuitry for decoupling the charging coil during periods of telemetry between the IPG and an external controller. Such decoupling circuitry can comprise use of pre-existing LSK circuitry during telemetry, or new discrete circuitry dedicated to decoupling. The decoupling circuitry is designed to prevent or at least reduce induced current flowing through the charging coil during data telemetry. The decoupling circuitry can be controlled by the microcontroller in the IPG, or can automatically decouple the charging coil at appropriate times to mitigate an induced current without instruction from the microcontroller.

A hermetic terminal for an active implantable medical device (AIMD), includes an RF distance telemetry pin antenna, a capacitor conductively coupled between the antenna and a ground for the AIMD, and an inductor electrically disposed in parallel with the capacitor and conductively coupled between the antenna and a ground for the AIMD. The capacitor and the inductor form a band pass filter for attenuating electromagnetic signals through the antenna except at a selected frequency band. Values of capacitance and inductance are selected such that the band pass filter is resonant at the selected frequency band. In an alternative form, the band pass filter is coupled in series with the telemetry pin antenna for attenuating MRI signals of a selected frequency band.

Embodiments of the present concept are directed to medical devices having features that prevent contaminants from infiltrating the housing of the device while providing a mechanism to provide clear auditory sounds to aid a rescuer in providing care to a patient. In one example, a medical device includes a housing having a transmission area associated with an enclosed voice coil. An exterior diaphragm formed integrally with the housing surrounds the transmission area and provides a watertight seal of the transmission area. In addition, the diaphragm is structured to generate a sound that can be heard by the rescuer from the voice coil.