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Insulet re-ups material deal with Flextronics
Insulet (NSDQ:PODD) said yesterday it extended a materials and manufacturing deal with Flextronics (NSDQ:FLEX) to produce and manufacture its Omnipod insulin management system for an additional 5...
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Stanford launches independent study of Fibralign’s BioBridge
Stanford University has begun enrollment in an investigator-led clinical study of Fibralign‘s BioBridge collagen matrix designed for treating secondary lymphedema, the company said yesterday. The...
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US FDA explains its approach to “real-world” evidence and data for medical...
By Stewart Eisenhart, Emergo Group Recent guidance from US medical device market regulators explains when and how real-world data and evidence obtained via methods other than clinical trials are used...
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Rox Medical raises $40m Series E for hypertension ‘stent’
Rox Medical said today that it raised a $40 million Series E round for the stent-like Coupler device it developed to treat hypertension by connecting the femoral artery and the femoral vein. The round...
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Boehringer Ingelheim touts Stiolto Respimat data
Boehringer Ingelheim yesterday touted results from a Phase III trial showing that its Stiolto Respimat, a drug-device combination helps people with chronic obstructive pulmonary disease walk for longer...
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Medtronic opens office in Vietnam
Medtronic (NYSE:MDT) said yesterday it opened a new office in Vietnam to greater serve the region. Fridley, Minn.-based Medtronic said it will “make important contributions” to fight cardiovascular...
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Biotronik hits the market in Japan with Ilivia MRI-safe ICD
Biotronik said yesterday it launched its Ilivia magnetic resonance imaging-safe implantable cardioverter defibrillator in Japan. The Berlin-based comapny said the Ilivia device features both its ProMRI...
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Edwards Lifesciences’ CardiAQ Valve wants to add $23m to Neovasc’s $70m trade...
Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies wants a federal judge in Massachusetts to add 33%, or more than $23 million, to the $70 million trade theft verdict lodged against...
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FDA: No evidence of data manipulation in clinical trials for Bayer’s Essure
The FDA said it completed a review of a trade complaint which alleged that Bayer (ETR:BAYN) was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation. The...
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Insulet taps ATS Automation Tooling for planned U.S. plant, beefs up...
Insulet (NSDQ:PODD) said today it inked a 5-year deal with ATS Automation Tooling Systems to construct an automated manufacturing assembly line for its products and announced a pair of new executive...
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Cardinal Health to pay up to $310m for Navidea’s LymphoSeek
Navidea (NYSE:NAVB) said today it inked a letter of intent with Cardinal Health (NYSE:CAH) to sell its Lymphoseek injection for up to $310 million. The sale includes all current FDA-approved...
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Tiny ‘fitbits’ to keep tabs on the body from within
(Reuters) – Scientists are developing dust-sized wireless sensors implanted inside the body to track neural activity in real-time, offering a potential new way to monitor or treat a range of conditions...
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MassDevice.com +5 | The top 5 medtech stories for September 6, 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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Alphatec closes $80m sale of int’l biz to Globus, announces 1-12 reverse split
Alphatec (NSDQ:ATEC) said it closed the $80 million sale of its international operations and distribution channels to Globus Medical (NYSE:GMED) and announced a 1-for-12 reverse stock split. Carlsbad,...
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Danaher to buy Cepheid in $4B deal to expand in diagnostics
(Reuters) –Danaher Corp. (NYSE:DHR) said on Tuesday it would buy molecular diagnostics company Cepheid in a deal valued at $4 billion, including debt, to strengthen its diagnostics business. Danaher...
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Teleflex to close N.C. plant, lay off 104
Teleflex (NYSE:TFX) is looking to shutter a North Carolina facility, with plans to lay off 104 employees at the facility. The company’s Ashboro subsidiary Arrow said in May it had plans to lay off 84...
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Olympus sues ex-CEO whistleblower Woodford
(Reuters) – Olympus (TYO:7733), the Japanese medical equipment and camera maker, is suing former CEO and whistleblower Michael Woodford in a multimillion-pound legal row over allegations of wrongdoing...
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Natus Medical logs 1st $20m payment in $121m contract with Venezuela
Natus Medical (NSDQ:BABY) said today it received an initial $20 million payment as part of a $120.7 million supply agreement between the Ministry of Health of Venezuela and its Buenos Aires,...
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Fresenius buys Spains largest private hospital chain for $6.4B
(Reuters) – German healthcare group Fresenius is buying Spain’s biggest private hospital chain Quironsalud for 5.8 billion euros ($6.4 bln), including assumed debt, in its biggest takeover ever. The...
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Insulet plans $250m debt offering
Insulet (NSDQ:PODD) said yesterday that it plans to fund a new, automated U.S. plant in part with the proceeds from a $250 million debt offering. Billerica, Mass.-based Insulet, which makes the Omnipod...
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