Partnering with larger players can prove essential to a small medtech company’s business strategy. But learning how to maneuver through collaborative relationships can be tricky. Part of Philips Healthworks’ mission is to help young companies grow by teaching them valuable skills, like how to establish partnerships. Senior director Brian Rosnov spoke with MassDevice.com editor Sarah […]
Reva Medical’s Fantom bioresorbable, drug-eluting vascular scaffold succeeds at 6 months
As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable […]
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. […]
Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting muscarinic antagonist and […]
Report: Boston Scientific could still seek to pull Synergy stent from India
Boston Scientific (NYSE:BSX) is reportedly still considering a market withdrawal in India for its Synergy adsorbable polymer stent, after repeated attempts to lift a government-imposed price cap were rebuffed by regulators there. Representatives from the Marlborough, Mass.-based medical device giant met yesterday with National Pharmaceutical Pricing Authority officials to discuss pulling Synergy from India, according to LiveMint. […]
Mazor Robotics wins CE Mark for Mazor X surgery platform
Mazor Robotics (NSDQ:MZOR) said today that it won CE Mark approval in the European Union for its Mazor X robot-assisted surgery platform, setting the stage for strategic backer Medtronic (NYSE:MDT) to put the device on the European market. “Receipt of the CE Mark is an important step in our plan to expand the patient, surgeon and hospital benefits […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
Catalent dishes out $950m for biologics manufacturer
Catalent said today that it plans to purchase Cook Pharmica for $950 million in cash. Cook Pharmica, a unit of privately-held medical device maker Cook Group, is a contract manufacturer that develops biologics-based drug compounds. Get the full story at our sister site, Drug Delivery Business News.
Micell raises $62m for MiStent SES
Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
CIRSE 2017 Round-up: Delcath touts second-gen hemofiltration system in percutaneous hepatic perfusion
Delcath Systems (NSDQ:DCTH) touted data today from a study of its second-generation hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan hydrochloride. The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark. The investigational product, an injectable melphalan hydrochloride for use with […]
Hill-Rom lands $45m Pentagon contract
Hill-Rom Holdings (NYSE:HRC) won a $45 million contract with the U.S. Defense Dept. to provide hospital equipment and accessories to the military and federal agencies. The Batesville, Ind.-based Hill-Rom unit that landed the five-year deal beat out 26 other bidders for the contract, the Pentagon said. There are no renewal options on the deal. The […]
- 1
- 2
- 3
- …
- 327
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
Google+