Dutch medical supplier Philips to pay more than $62m to settle FCPA charges

By NS Medical Staff Writer

15 May 23

In April 2013 the Commission charged Philips in connection with similar misconduct in Poland that had occurred between 1999 and…

RegulationRegulatory Policy

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

By NS Medical Staff Writer

20 Mar 23

Company Must Stop Marketing Unauthorized Products

RegulationRegulatory Policy

Click Therapeutics’ CT-132 gets FDA breakthrough status in episodic migraine

By NS Medical Staff Writer

19 Dec 22

Presently under development, the CT-132 digital therapeutic candidate has secured the FDA designation in patients of age 18…

DevicesRegulationRegulatory Policy

European Commission blocks Illumina’s $8bn acquisition of GRAIL

By NS Medical Staff Writer

07 Sep 22

Illumina announced that it is reviewing the EC's order on blocking the deal, while revealing its intention to…

DevicesRegulatory PolicyDiagnostic Devices

FDA and ECRI Partner on Materials Safety in Medical Devices

By NS Medical Staff Writer

01 Oct 21

ECRI's comprehensive evidence-based studies examine safety and risks of materials used in implantable medical devices; research will aid…

RegulationRegulatory Policy

Accelerating time to market with regulatory information management systems

ByDave Hadfield, Kalypso

16 Apr 21

Regulatory information management systems have existed for decades, but over time have matured significantly, especially in recent years

RegulationRegulatory Policy

MHRA urges people to continue getting vaccinated following Irish suspension of AstraZeneca jab

By Jamie Bell

15 Mar 21

The MHRA stated 'the evidence available does not suggest the vaccine is the cause' following reports of blood…

RegulationRegulatory Policy

FDA warns 25 companies to stop producing fake regulatory certificates for medical devices

By Jamie Bell

05 Mar 21

The FDA has written to 25 companies - including manufacturers, distributors and sellers - telling them not to…

RegulationRegulatory Policy

How to obtain a CE mark for your medical device under the upcoming EU regulations

BySophie Laurenson, Kolabtree

17 Feb 21

Kolabtree's Sophie Laurenson discusses how manufacturers should go about gaining a CE mark for their medical devices under…

RegulationApprovals

Adoption of ‘incredibly helpful’ AI and ML technologies set to surge following FDA action plan

By Jamie Bell

15 Feb 21

Last month, the FDA introduced a five-point action plan to help integrate AI- and ML-powered technologies into the…

RegulationRegulatory Policy