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Diagnostics & Healthcare News
House Votes to Repeal Obamacare’s Medical Device Tax
The U.S. House of Representatives voted 283-132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act. The medical device tax, which has long been decried by the industry as a measure...
July 25, 2018
Diagnostics & Healthcare News
Biotech Manufacturing is Booming with Growth of Biologics and Gene Therapies
Manufacturing is the non-glamorous side of biopharma, although its impact on the economy shouldn’t be underestimated. For example, a recent report published by TEConomy and BIOtitled, “Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry 2018,” reported that the average wage in bioscience...
July 18, 2018
Diagnostics & Healthcare News
Axonics Receives CE Mark for Sacral Neuromodulation External Trial System
Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, announced today that it has received the CE mark for its Sacral Neuromodulation External Trial System. Axonics received CE mark in June 2016 for...
July 9, 2018
Diagnostics & Healthcare News
Breath Biopsy Platform Wins UK’s Most Prestigious Award for Innovative Engineering
Owlstone Medical, a diagnostics company developing a breathalyzer for disease, has announced the team behind the Company’s unique Breath Biopsy® platform has been named the winner of the MacRobert Award 2018 by the Royal Academy of Engineering. Owlstone Medical’s Breath...
July 6, 2018
Diagnostics & Healthcare News
Massachusetts Biotech Sees Record Year for IPOs
It’s been a pretty good year for mergers and acquisitions in the biopharma industry, with Takeda Pharmaceutical buying Shire for $62.2 billion, and the year starting with Sanofi buying Bioverativfor $11.6 billion and then Ablynx for $4.8 billion. Celgene acquired Juno Therapeutics for $9 billion, shortly after buying Impact Biomedicines for $1.1 billion. But the landscape for...
July 2, 2018
Diagnostics & Healthcare News
GE to Spin Off Healthcare Division
After a year of soul searching and strategic review, GE announced its move today to spin off GE Healthcare into a standalone company over the next 12 to 18 months. The goal, the company said, is a leaner corporate structure...
June 26, 2018
Diagnostics & Healthcare News
FDA Approves First Marijuana-derived Drug for Severe Forms of Epilepsy
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older....
June 25, 2018
Diagnostics & Healthcare News
White House Proposes 30% Cut to FDA Headcount
The Trump administration this week submitted a proposal that would cut the budget and staff at the FDA, as well as reorganizing the agency to remove food regulation from its purview, according to a new Endpoints News report. The proposal would cut...
June 22, 2018
Diagnostics & Healthcare News
World’s First Long-Term Implantable Glucose Monitoring Device Now FDA Approved
GERMANTOWN, Md., June 21, 2018 — Senseonics Holdings, Inc. (NYSE American: SENS) today announced the U.S. Food and Drug Administration has approved its Pre-market Approval (PMA) application to market the company’s Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes...
June 22, 2018
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