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Final guidance issued by FDA for IDE benefits and risks
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration lays out key factors the agency uses to assess benefits and risks of Investigational Device Exemption (IDE)...
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Allergan pays $15m for failing to disclose Actavis ‘white knight’ offer
The SEC said yesterday that Allergan (NYSE:AGN) will pay a $15 million fine for failing to disclose its 2014 merger talks with Actavis. In June 2014, Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) offered...
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Derma Sciences pays $13m for Medihoney ahead of Integra buyout
Derma Sciences (NSDQ:DSCI) said last week that it paid $13.3 million for Medihoney, on the same day that Integra LifeSciences (NSDQ:IART) agreed to pay nearly $200 million for the tissue regeneration...
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Abbott launches dorsal root ganglion neurostim system in Europe
Abbott (NYSE:ABT) said today that it launched its Proclaim dorsal root ganglion neurostimulation system in Europe for patients suffering from chronic neuropathic pain. The Abbott Park, Il.-based...
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Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor
Edwards Lifesciences (NYSE:EW) said yesterday that it won CE Mark approval in the European Union for its HemoSphere blood flow monitor. Hemodynamic monitoring, the measurement of a patient’s blood...
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Braeburn sets terms for $150m IPO
Braeburn Pharmaceuticals said today that it plans to raise $150 million by offering 7,692,308 shares of its common stock. The Princeton, N.J.-based company wrote in regulatory filings that it expects...
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Orthofix to pay $14m to settle foreign bribery beef with SEC
The SEC said today that Orthofix (NSDQ:OFIX) has agreed to cough up more than $14 million to settle federal charges that it improperly booked revenue and made improper payments to doctors at...
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Sanofi’s SuliquaTM combination therapy approved in European Union
Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its SuliquaTM combination product for adults with type II diabetes. The therapy is a fixed-ratio...
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Corindus jumps on raised outlook
Shares in Corindus Vascular Robotics (OTC:CVRS) jumped nearly 11% in morning trading today after the company raised its outlook for full-year revenue in 2017 to between $13 million – $15 million....
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From Zero to Six Million – Using a Component Management Process to Scale Up...
Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new...
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MassDevice.com +5 | The top 5 medtech stories for January 18, 2017
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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FDA issues guidance for off-label communications for drugs & devices
The FDA issued 2 draft guidances today to clarify the federal watchdog’s recommendations for communications regarding medical products, including off-label information and communicating...
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EnteroMedics prices $17m offering
EnteroMedics (NSDQ:ETRM) priced today its underwritten public offering at $16.5 million, offering class A units priced at $5.31 apiece and class B units at $1,000 apiece. Each class A unit consists of...
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Donald Trump: 5 questions medtech needs to ask
[Image courtesy of Zach Rudisin, CC BY-SA 3.0]From tax breaks to Obamacare repeal, medtech companies are likely due to experience major changes under President Donald Trump. The situation, though,...
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Heart failure devices: This amazing new robot could be the future
[Image courtesy of Ellen Rouche/Harvard SEAS]A new customizable robotic heart sleeve has demonstrated potential when it comes to aiding the beating of a failing heart, according to the Harvard...
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Introducing IMEDS, a public-private resource for evidence generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry,...
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Trump’s HHS pick defends ACA repeal and replacement
President-elect Donald Trump’s nominee for Health and Human Services Department secretary—Rep. Tom Price (R-Ga.)—maintained during a Senate committee hearing on Wednesday that the incoming...
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Coorstek claims win in ceramic hip dispute
A federal judge in Colorado ruled earlier this month that Ceramtec cannot trademark its ceramic hip implants’ pink color, after the company wrote a cease and desist letter to Coorstek Medical in 2014...
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Judge dings Neovasc for another $21m in spat with Edwards Lifesciences unit...
A federal judge in Boston yesterday added another $21 million to the judgment against Neovasc (NSDQ:NVCN) in a trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve that’s...
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InVivo adds patient to regenerative spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that it enrolled a new patient in the Inspire study of its neuro-spinal scaffold. Principal investigator Dr. Travis Dumont performed the implantation earlier...
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