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 news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. FDA draft guidance on 510(k)s omits combination devices
Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA.
The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years old. Read more
4. Neovasc shares tumble on Q2 release with $70m set aside to cover loss to Edwards’ CardiAQ Valve
Neovasc shares have plummeted nearly 20% after saying it set aside $70 million to cover a loss in an ongoing patent battle with Edwards Lifesciences subsidiary CardiAQ Valve Technologies in its 2nd quarter earnings release.
The company said that both parties are pursuing post-trial motions, including an injunction from CardiAQ that would require Neovasc to cease Tiara operations for 18 months. Read more
3. UPDATE: Private equity players prep nearly $1B offering of Zimmer Biomet shares
A pair of private equity players are readying an offering of Zimmer Biomet shares that could be worth nearly $1 billion.
Warsaw, Ind.-based Zimmer Biomet said KKR and TPG Capital are planning to sell more than 7.4 million ZBH shares at $129.75 each, for proceeds of $965.4 million. Read more
2. Medicrea raises $22m, taps Globus Medical co-founder Kienzle
Medicrea said it raised a funding round worth about $22.3 million for its UniD patient-specific spinal rod technology and tapped GMEd co-founder Richard Kienzle as its new chief commercial & business development officer.
New York City and Lyon, France-based Medicrea said the €20 million round consisted of about $16.8 million (€15 million) in 4-year, 6.75% convertible bonds due August 12, 2020 bought by Athyrium Capital Management and another $5.6 million (€5 million) in equity. Read more
1. Apple CEO Cook: Healthcare may make smartphone market ‘look small’
Apple CEO Tim Cook says that the healthcare market’s potential could dwarf the smartphone market that accounts for some 65% of Apple’s $234 billion in annual revenues.
The consumer electronics giant – which is rumored to be developing a stand-alone device to monitor heart rate, pulse, blood and sugar changes – has a significant advantage over medical device and drug manufacturers, Cook told FastCompany.com. Read more
