The UK government is preparing for a “worst-case” Brexit scenario in which no deal is reached between the country and the European Union by March 29, the date the country is slated to leave the EU, according to a recent release from UK health minister Matt Hancock. Preparations include increasing the stock holding capacity in […]
BioCardia submits bid for FDA clearance of Avance transseptal introducer
BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
Report: India still lacks solid medical device regulation
It has been 13 years since Indian health authorities were directed to create a framework for medical device regulation, but only 23 of 5,000 product categories are currently regulated, according to a report from the Hindu BusinessLine. In 2005, a Chief Justice at the Bombay High Court overhearing a case involving drug-eluting stents was shocked […]
NuVasive wins expanded FDA nod for Monolith corpectomy system
NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures. The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction […]
FDA clears Contego Medical’s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues […]
Meril Life Sciences wins approval for TAVR in India
Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
What is the future of medtech in 2019?
A global push to increase medical device industry regulation and the continued blurring of high tech and medtech – those are but some of the predictions that Medical Design & Outsourcing editors are hearing from experts. Read on to discover some of the top predictions of where the industry is going in 2019. Next>> Senior […]
Olympus wins FDA nod for Spiration bronchial valve
Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device. The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during […]
FDA warns Globus subsidiary HBT over ViaCell production facility issues
The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective […]
FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency […]
FDA floats changes to De Novo pathway
The FDA this week published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway. If the rule is finalized, it would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. The proposed rule would also establish requirements for the formatting […]
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