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Senate bill looks to streamline CMS pathway for “breakthrough” devices
The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices. The bill, titled the “Ensuring Patient Access to Critical...
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Nephros inks distro deal with CS Medical
Nephros (OTC:NEPH) said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram...
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Fighting opioid addiction with medical devices: FDA approves new implant
The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog. The matchstick-sized Probuphine implant,...
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Thermo Fisher picks up electron microscopy firm FEI for $4.2B
Thermo Fisher (NYSE:TMO) said today it bought electron microscopy developer FEI Company for $4.2 billion, through the acquisition of stock at $107.5 per share in cash. FEI designs, manufactures and...
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Report: Insurer accuses Intuitive of hiding over 700 injury claims
Two insurance companies are claiming that Intuitive Surgical (NSDQ:ISRG) failed to reveal more than 700 injury claims when it applied for liability coverage, according to a new report from Bloomberg....
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MassDevice.com +5 | The top 5 medtech stories for May 27, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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EndoGastric Solutions launches EsophyX Z device designed to treat GERD
EndoGastric Solutions said today it launched its EsophyX Z device designed for treating gastroesophageal reflux disease, and that the device was used in its 1st treatment procedure. The 1st procedure...
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House panel look to ease FDA’s curbs on off-label marketing
A U.S. House of Representatives committee wants to amend the Food, Drug & Cosmetic act to ease the FDA’s ban on off-label marketing of medical devices and drugs. The House Energy & Commerce...
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Clearside Biomedical floats $50m IPO
Clearside Biomedical raised $50 million with its initial public offering, floating 7.2 million shares at $7 apiece. That’s below the range Clearside earlier set for the IPO, when it planned to put up...
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Fujufilm, jilted in Toshiba Medical sale, still hot to trot the M&A trail
Fujifilm Holdings (TSE:4901), which lost out in March to Canon (NYSE:CAJ) in the race for Toshiba‘s (TYO:6502) medical device business, is still hot to trot on the mergers & acquisitions trail. New...
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Intarcia, Numab log milestones for autoimmune drug-device combo
Intarcia Therapeutics and pharmaceuticals maker Numab said today that they’ve logged several milestones in their joint project to develop a drug-device combination for treating inflammatory and...
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Medtronic recalls Midas Rex sagittal saws on leaky seals risk
Medtronic (NYSE:MDT) said in late May it initiated a voluntary field action to recall its Midas Rex Sagittal Saws over issues with potential leakage of fluid into the motor through the units Rocker...
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Gore wins CE Mark for Excluder stent graft
W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging...
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Exthera Medical closes $15 million Series B for Seraph blood infection filter
Updated to correct funding amounts and include new information from Exthera. By Fink Densford & Varun Saxena Martinez, Calif.-based Exthera Medical said it raised a $15.3 million Series B round...
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MassDevice.com +5 | The top 5 medtech stories for June 2, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Occlutech wins CE Mark for LAA occluder
Structural heart disease implant developer Occlutech said today it won CE Mark approval in the European Union for its Left Atrial Appendix occluder device designed for the minimally invasive closure of...
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FDA clears Esco Medical’s Miri TL embryo incubator
In vitro fertilization business Esco Medical said today the FDA granted 510(k) clearance to its Miri Time-Lapse embryo incubator. The newly cleared Miri TL is designed as a multi-room incubator with a...
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FDA looks to speed compassionate use applications
The FDA is finalizing steps to streamline the process used by physicians to request “compassionate use” access to investigational drugs and devices for their patients, according to FDA Commissioner Dr....
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J&J to buy hair care products maker Vogue for $3.3 bln
(Reuters) – Johnson & Johnson (NYSE:JNJ) said on Thursday it would acquire Vogue International for $3.3 billion, adding brands such as OGX shampoos and FX hair styling products to its consumer...
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Mirabilis Medica raises $5.2m for uterine fibroid treating device
Uterine fibroid-treating device developer Mirabilis Medica raised $5.2 million in a new round of debt financing, according to an SEC filing posted today. The company’s Mirabilis system is designed to...
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