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FDA

Provider of medical scalp cooling technology, Dignitana, has announced that it has received clearance from the FDA to expand the use of its medical device to patients in the US receiving chemotherapy for solid tumour cancers. more

Jul 7, 2017 11:55 AM Devices

Pyam Ramnes examines the improvement of the design of catheter material. more

Jun 27, 2017 12:15 PM News

Vancive Medical Technologies has teamed up with Eloquest Healthcare on a line of transparent post-operative dressings designed to enhance patient care. The device has received 510(k) clearance from the FDA. more

Jun 21, 2017 1:50 PM News

The FDA has released a statement regarding plans that help regulate digital health technologies. more

Jun 19, 2017 10:45 AM News

A spinout company from the Irish software research centre Lero, has developed a new cybersecurity risk management software application for North American medical device manufacturers. more

Jun 7, 2017 10:40 AM News

The Flourish Pediatric Esophageal Atresia Anastomosis, is said to be a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their oesophagus, called oesophageal atresia. more

May 15, 2017 9:58 AM Devices

Dr Scott Gottlieb, former FDA deputy commissioner, has been confirmed as the agency’s next chief. This comes around four months after Robert Califf, selected by Obama, stepped down. more

May 11, 2017 11:14 AM News

Medical device company Medtronic has gained FDA approval of its Resolute Onyx drug-eluting stent. more

May 10, 2017 9:30 AM Devices

US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics. more

May 9, 2017 10:05 AM News

Lu Rahman examines the growing issue of cybersecurity and medical devices. more

May 9, 2017 9:30 AM News

The FDA has given Nanobiosym Diagnostics Emergency Use Authorization (EUA) for its Gene-RADAR Zika virus test. The portable medical device means it can be used in hospitals and offers fast, accurate results. more

May 2, 2017 10:08 AM Devices

APMT explains how its ACOMP system provides real-time monitoring, characterisation and control of polymer properties for medical applications. more

Apr 27, 2017 2:50 PM Opinion

Hand-held, non-invasive medical device provides new option for the approximately 400,000 Americans living with this rare but extremely debilitating headache disorder more

Apr 21, 2017 12:45 PM Devices

The Food and Drug Administration (FDA) has warned medical device maker Abbott that it must submit a plan to address any cybersecurity issues and other safety issues identified in cardiac devices from the company’s recently acquired St Jude Medical. more

Apr 21, 2017 10:00 AM News

Novatek Communications, provider of technical documentation and training services, has launched an Instructions for Use (IFU) template to support the product launch needs of medical device companies. more

Apr 21, 2017 10:00 AM News

The US Food and Drug Administration (FDA) has cleared Paxman Coolers to market its Paxman Scalp Cooling System. more

Apr 19, 2017 9:24 AM Devices

Medical research institutions in the US have spoken out against president Donald Trump’s proposals to cut almost 20% of funding from the National Institutes of Health (NIH). more

Mar 20, 2017 12:20 PM News

Stephen Duckworth, Clariant Plastics and Coatings, uses his expertise in healthcare polymer solutions to explain why plastic component design options begin with a secure supply chain. more

Feb 27, 2017 11:40 AM News

Custom compounder of medical-grade formulations, Colorite, has launched a new line of thermoplastic elastomer (TPE) compounds for medical device applications at MD&M West. more

Feb 7, 2017 9:00 AM News

Knowing what's involved when medical devices are reprocessed can help manufacturers understand what’s needed in the design and material choice. Stephen Spiegelberg, Cambridge Polymer Group, explains more

Feb 1, 2017 9:00 AM News