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FDA

Five people have died due to issues with weight-loss balloon devices since 2016, the FDA has announced. more

21 Sep 2017 16:00 Devices

Medical Plastics News takes a look at some of the biggest stories that have emerged over the past week. more

4 Sep 2017 16:05 News

The FDA has released guidance for medical device makers on the use of real-world data (RWD) and real-world evidence (RWE) in gaining approval for their products. more

1 Sep 2017 14:25 News

MPN has been flying the flag for digital health for a few years now and thanks to our sister site DigitalHealthAge.com we report on the latest trends and technology coming out of this exciting sector. more

1 Sep 2017 09:50 Opinion

Over 500,000 pacemakers developed by medical device maker Abbott have been shown to contain cyber-security issues. more

31 Aug 2017 10:25 Devices

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

7 Jul 2017 11:55 Devices

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

27 Jun 2017 12:15 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

21 Jun 2017 13:50 News

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

19 Jun 2017 10:45 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

7 Jun 2017 10:40 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

15 May 2017 09:58 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

11 May 2017 11:14 News

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

10 May 2017 09:30 Devices

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

9 May 2017 10:05 News

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

9 May 2017 09:30 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

2 May 2017 10:08 Devices

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

27 Apr 2017 14:50 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

21 Apr 2017 12:45 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

21 Apr 2017 10:00 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

21 Apr 2017 10:00 News