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. Researchers: Short-seller’s claims about St. Jude Medical devices have ‘major flaws’
A short-seller’s report that cardiac rhythm management devices made by STJ are vulnerable to hackers has “major flaws” and doesn’t prove its allegations, according to researchers from the University of Michigan.
Muddy Waters, the firm founded by well-known short-seller Carson Block, last week aimed to disrupt the pending, $25 billion acquisition of St. Jude by Abbott; in addition to his bet that STJ share prices will fall, Block is long on ABT shares. His shop and a startup cybersecurity business called MedSec alleged last week that St. Jude’s implanted cardiac rhythm management devices pose a cybersecurity risk due to vulnerabilities in the Merlin@home monitor. Read more
4. FDA releases June 2016 510(k) clearances
The FDA released the full list of 510(k) clearances it granted for June 2016. Read more
3. Genstar Capital shops Tecomet for $1B
Private equity player Genstar Capital is reportedly shopping Tecomet to potential buyers for more than $1 billion.
Genstar tapped investment bank William Blair & Co. to auction Tecomet, according to Reuters, which cited “people familiar with the matter.” Genstar, Tecomet and William Blair declined to comment. Read more
2. FDA releases July 2016 510(k) clearances
The FDA released the full list of 510(k) clearances it granted for July 2016. Read more
1. Judge blocks FDA’s move to shutter Amniotic Therapies
A federal judge this month blocked the FDA’s bid to force Amniotic Therapies to shut down completely, ruling instead that the maker of placental tissue-based wound-healing products must only cease distribution until a hearing slated for today in a Texas court.
The federal safety watchdog ordered the shutdown August 16 and slapped Farmers Branch, Texas-based Amniotic Therapies with a warning letter the next day. The FDA ordered the company to immediately stop manufacturing human cells, tissues or cellular-tissue-based products (HCT/Ps) and recall and destroy all product made since Sept. 11, 2014, within 5 days of receiving the order. The shutdown was to last “until compliance with the regulations … has been achieved and you have been provided written authorization from FDA to resume operations,” according to court documents. The warning letter flagged problems with the manufacture of the company’s other products, AlphaGEMS Micro and AlphaGEMS Nano. Read more
