Integra LifeSciences (NSDQ:IART) and Dr. Reddy’s Laboratories (NYSE:RDY) inked an exclusive distribution agreement for the DuraGen Plus and suturable DuraGen Dural Regeneration Matrices in India. According to the deal, Dr. Reddy’s will market and distribute the medical devices throughout India. The DuraGen Plus Dural Regeneration Matrix is indicated as a dural susbtitute for the repair of […]
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EU regulators: We should suspend drugs at suspect Indian facility
This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. European officials have reportedly […]
Researchers win $1.8m NIH grant to develop implantable system for HIV prevention
Researchers at the University of North Carolina at Chapel Hill won a $1.8 million grant from the National Institutes of Health to develop an implantable drug delivery system for sustained HIV-prevention. The team said it plans to develop an injectable system that steadily releases pre-exposure prophylaxis over long periods of time. The injectable compound is […]
Organogenesis launches PuraPly antimicrobial clinical program
Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis. The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The […]
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
Medtech stories we missed this week: March 24, 2017
From companies receiving CE marking to other companies adjusting their distribution deals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. […]
Researchers tout preclinical results for one-shot vaccination method
Researchers from Boston Children’s Hospital said today that they achieved strong vaccine responses in preclinical models by adding adjuvants to boost the immune response. The team’s work was published the Journal of Clinical Investigation-Insight and the Journal of Allergy and Clinical Immunology. Vaccines have the potential to drastically reduce infant mortality, the researchers said, but newborns often don’t […]
The top medtech stories of early 2017
The new Trump administration and Republican Congress – and all the accompanying change and uncertainty – is the major story for the medical device industry. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, diabetes […]
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
Study: Laser-activated gold microstructures deliver cargo directly into cells
Researchers from the Harvard University’s John A. Paulson School of Engineering and Applied Sciences have developed a method to deliver molecules into cells using gold microstructures. The team published their work in ACS Nano. Previous work has been done to deliver drugs or DNA into cells by tricking or forcing open the cell membrane, but the […]