Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won […]
Nemaura Medical wins CE Mark for SugarBeat CGM
Nemaura Medical (NSDQ:NMRD) said yesterday that it won CE Mark approval for its SugarBEAT continuous glucose monitor. The SugarBEAT CGM is a flexible, disposable patch that’s connected to a rechargeable transmitter and Bluetooth-enabled smartphone app, designed to deliver glucose readings at five-minute intervals throughout the day. The company says the device allows users to spend more […]
India regulators list risk classifications for 12 notified medical devices
By Stewart Eisenhart, Emergo Group The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
EPTAM Precision Solutions acquires Micro Molding and MedConnection
Heritage Portfolio’s EPTAM Precision Solutions today announced that it has acquired Micro Molding and MedConnection. The financial details of the deal were not disclosed. Phillipsburg, N.J.-based Micro Molding is a precision plastic injection component manufacturer that serves the medical device market. It offers precision injection molding, catheter tipping, finishing and assembly. It has two ISO-9001 […]
FDA readies for SaMD Pre-Cert program test cases
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical device (SaMD). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Medtronic touts huge real-world data set for MiniMed 670G
Patients using a smart insulin pump system made by Medtronic (NYSE:MDT) spent more time in a healthy blood glucose range, according to real-world data from more than 8 million patient days. The MiniMed 670G is designed to automatically track and adjust blood sugar levels, using a continuous glucose monitor, guiding patients toward a minimum level of […]
TÜV Süd becomes second Notified Body to European MDR
By Ronald Boumans, Emergo Group TÜV Süd is now the second Notified Body designated to issue CE Mark certifications under the upcoming European Medical Devices Regulation (MDR). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
FDA approves Novocure’s NovoTTF-100LTM plus chemo for mesothelioma
NovoCure (NSDQ:NVCR) announced that it has received FDA approval for its NovoTTF-100L system with chemotherapy for treating a type of mesothelioma. NovoTTF-100L is a non-invasive, antimitotic cancer treatment designed to deliver electric fields at special frequencies to disrupt solid tumor cancer cell division. Approved under a humanitarian device exemption, NovoTTF-100L and pemetrexed plus platinum-based chemotherapyis indicated […]
How MDR will affect drug-device combination product manufacturers
By Stewart Eisenhart, Emergo Group The European Medicines Agency (EMA), which oversees the European Union’s pharmaceutical market, has begun rolling out guidance and clarifications regarding Medical Devices Regulation (MDR) compliance issues for manufacturers of combination products with drug and medical device components. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
FDA OKs AngioDynamics trial for NanoKnife in prostate cancer
AngioDynamics (NSDQ:ANGO) today announced the FDA has approved its investigational device exemption application for its NanoKnife irreversible electroporation pilot study. The non-randomized pilot study will include six subjects at up to three sites and is designed to inform the design of a pivotal clinical study in the U.S. to help support the company’s bid for pre-market […]
Ocular Therapeutix OTX-TP trial misses primary endpoint
A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure. OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure. The randomized, double-blind, placebo-controlled clinical trial took place across more […]