Tag: Medical Devices

Progenity to Acquire Assets of Medimetrics Ingestible Device

Progenity, Inc, a privately held biotechnology company, has acquired assets of ingestible device company Medimetrics GmbH. This acquisition further strengthens Progenity’s existing intellectual proper...

FDA Publushed Draft Guide on Strengthening 510(k) Medical Device Program

medical-devices
The U.S. Food and Drug Administration announced that, as the first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuin...

Philips to Launch Therapy Device for Patients with OSA

Royal Philips, a global leader in health technology, announced the commercial launch of Philips NightBalance, a prescription sleep position therapy device designed for patients with positional obstruc...

FDA Released Draft Guidance on New Safer Technologies Program

The US Food and Drug Administration (FDA) released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the...

Market Share of Locally Produced Medical Devices in Russia to Increase to 40% by 2024

medical-devices
The market share of Russian medical devices due to the implementation of the National Healthcare project will increase from 23 to 40% by the end of 2024, said the Minister of Industry and Trade of the...

Abbott Announced European Approvals for Two Life-Saving Pediatric Devices

abbott
Abbott announced approvals in Europe for two of its life-saving pediatric devices. The Masters HP™ 15mm rotatable mechanical heart valve and the Amplatzer Piccolo™ Occluder have received CE Mark and a...

Russian Government Extended Medical Devices’ List Not Subject to VAT

medical-devices
On 19 August 2019 the Russian government published resolution no. 1054 and extended the list of medical devices which are not subject to VAT. It should be recalled that the list was launched in 201...

Changes to the Russian Regulation of Medical Devices Come into Force

medical devices
On August 9, 2019, Roszdravnadzor’s order No. 3239 from April 25, 2019 “On approval of the administrative regulations of the Federal Service for Supervision of Health Care for the provision of public ...

FDA Approved First Spinal Tether Device to Treat Children with Progressive Idiopathic Scoliosis

The U.S. Food and Drug Administration approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis,...

FDA Approved Barostim Neo System for Improvement of Symptoms in Patients with Advanced Heart Failure...

The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure...

Germany-Based Dekra Certification Designated as Third Notified Body Under MDR

medical-devices
The European Commission announced that Germany-based Dekra Certification GmbH is the third notified body (NB) to be designated under the Medical Devices Regulation (MDR). Dekra joins Germany-based ...

EEC Intends to Extend Transition Period for Re-Registration of Medical Devices

EAEU
The Eurasian Economic Commission of the Eurasian-Asian Economic Union (EAEU) intends to extend the transition period for re-registration of medical devices with a registration certificate in their cou...

FDA Released Updated Guidance on Devices in the Magnetic Resonance Environment

fda
The draft guidance issued offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment. Once finalized, the 26-pa...

Australian TGA Expressed Concern over Shortage of European NBs

med-devices
The TGA (Australian Therapeutic Goods Administration) has expressed concern about a looming shortage of Notified Bodies under the new Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR)...

European Implementation of Medical Device and IVD Regulations – Implications for Australia

Many sponsors of medical devices and in vitro diagnostic (IVD) devices use manufacturer's conformity assessment certification issued by European notified bodies to support applications for marketing a...

FDA Recognized Consensus Standards for Medical Device Interoperability

fda office
The latest batch of US Food and Drug Administration (FDA) recognized consensus standards marked several firsts for the agency, including for interoperability and safety assurance cases. FDA’s Cente...