USA -
FDA Backs Off From Regulating Certain Types of Health Software

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

One of the draft guidances, the 13-page “Clinical and Patient Decision Support Software,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated.

“For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” FDA Commissioner Scott Gottlieb, who testified before the Senate Committee on Health, Education, Labor & Pensions on Wednesday, said in a statement...

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USA -
Weight-Loss Balloon Maker to Serve Up $35M Offering

Obalon Therapeutics, developer of the first FDA-approved swallowable, gas-filled balloon for obesity treatment, is preparing an underwritten public offering of its common stock. Obalon Therapeutics is hoping to raise some funds through a public sale of $35 million worth of its common stock. The San Diego, CA-based company developed the first FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, which FDA approved in September 2016. The offering could fetch an additional $5.25 million if the underwriters' over-allotment option is exercised in full. The...

Europe -
New European Borderline and Classification Manual Published

An updated version of the European Borderline and Classification Manual for medical devices and IVDs is now published. The latest manual will be of limited use once the European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) go into effect because of different definitions and classification rules. Manual on Borderline and Classification in the Community regulatory framework for medical Devices

France -
L'AP-HP ouvre une plateforme d'évaluation et d'analyse scientifique des objets connectés de santé

L'Assistance publique-hôpitaux de Paris (AP-HP) a annoncé le 10 janvier la création de "la première plateforme d'évaluation et d'analyse des objets connectés en santé", intitulée "Digital Medical Hub" (DMH), avec le soutien de plusieurs acteurs privés, publics et institutionnels. Créée à l'hôpital Bichat-Claude Bernard en partenariat avec la Fondation de l'AP-HP pour la recherche et avec le soutien du laboratoire MSD France et de la Fondation du Souffle, cette plateforme entend "se positionner comme un centre de référence pour le développement et la validation clinique" des objets connectés...

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