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FDA warns two breast implant makers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

20 Mar 2019

New $9.7 million NIH grant project seeks to improve hearing restoration

The University of Minnesota announced today that it will lead a $9.7 million grant over the next five years from the National Institutes for Health BRAIN Initiative to develop a new implantable device and surgical procedure with the goal of restoring more natural hearing to people who are deaf or severely hard-of-hearing.

20 Mar 2019

Researchers receive $9.7-million grant to develop new hearing-loss treatments for deaf

A team of worldwide researchers including engineers from the University of Utah have received a $9.7-million grant to design and develop a new implantable device and surgical procedure for the deaf that hopefully will cut through the noise and produce much more detailed sound than traditional hearing-loss treatments.

20 Mar 2019

MSU professor wins prestigious award for brain research

Some electrical engineers design the giant dynamos and transmission lines that power society. Others apply their prowess to electronics in cars and televisions, or -- still smaller -- the microprocessors in phones and watches.

15 Mar 2019

Evonik introduces new radiopaque PEEK material for medical implants

Evonik is expanding its product range of biocompatible high-performance polymers of its VESTAKEEP® PEEK brand for medical technology.

From Evonik 13 Mar 2019

Bedfont receives manufacturing accolade in GHP Biotechnology Awards

Bedfont have been named Best Breath & Gas Monitoring Instruments Manufacturer 2019 in the Global Health & Pharma Biotechnology Awards.

From Bedfont® Scientific Ltd 11 Mar 2019

FDA takes action to help reduce risks linked with use of surgical staplers and staples

Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples - common devices used in many surgeries - and to provide updated recommendations to help reduce risks associated with their use.

11 Mar 2019

FDA announces sweeping plan to review safety of surgical staplers

The Food and Drug Administration announced a sweeping plan on Friday to review and address the safety of surgical staplers, including a new examination of seven years' worth of hidden reports highlighted Thursday in a Kaiser Health News investigation.

9 Mar 2019

Podcast: KHN’s ‘What the Health?’ What’s next for the FDA?

The resignation of Scott Gottlieb as commissioner of the Food and Drug Administration caught many FDA watchers by surprise. Gottlieb has been an active regulator in a very anti-regulatory Trump administration.

7 Mar 2019

Hidden FDA reports detail harm caused by scores of medical devices

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

7 Mar 2019

Patients question how FDA approves medical devices

There’s no doubt that surgically implanted medical devices can improve lives. Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones.

6 Mar 2019

Laser-based technique allows doctors to image the whole eye in 3D

Scientists have developed a laser-based technique that can produce a full 3D image of all the layers of the retina, allowing doctors to better diagnose and treat eye diseases such as cataracts, diabetic retinopathy, and cancer.

6 Mar 2019

Gottleib resigns from FDA – issue of rising teen vaping remains unsolved

Scott Gottlieb, the commissioner of the United States Food and Drug Administration (FDA) has announced that he would resign from office at the end of this month.

5 Mar 2019

Bedfont signs multiyear ODM agreement with MGC Diagnostics Corporation

Kent medical device manufacturer, Bedfont Scientific Ltd., signs a multiyear ODM deal to supply MGC Diagnostics Corporation with its new NObreath®.

From Bedfont® Scientific Ltd 4 Mar 2019

MD&M West 2019: Medical Devices, 3D Printing and Staying Compliant

Between February 5 - 7 2019, the Anaheim Convention Center in Southern California hosted the annual MD&M West medical manufacturing conference.

27 Feb 2019

FDA warns Total Thermal Imaging for illegally marketing unapproved thermography device

The U.S. Food and Drug Administration has issued a warning letter toTotal Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases.

25 Feb 2019

FDA’s new proposed rule would update regulatory requirements for sunscreen products in the U.S

The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.

22 Feb 2019

Bedfont Scientific named Exporter of the Year at SEHTA Awards

Bedfont Scientific Ltd.

From Bedfont® Scientific Ltd 21 Feb 2019

FDA authorizes new interoperable insulin pump for children, adults with diabetes

The U.S. Food and Drug Administration today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes.

15 Feb 2019

FDA warns doctor for illegally marketing unapproved implantable device

Today, the U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue.

14 Feb 2019