Clik here to view.
FDA rejects Amphastar subsidiary’s Primatene Mist asthma inhaler
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response...
View ArticleClik here to view.
Nikon’s Optos, Google’s Verily ink deal for machine learning in retinal imaging
Nikon (TYO:7731) subsidiary Optos and Google (NSDQ:GOOG) unit Verily inked a deal this week to develop technologies for machine learning-enabled retinal imaging. The deal calls for the companies will...
View ArticleClik here to view.
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket...
View ArticleClik here to view.
Humacyte launches Phase II trial for artificial bypass graft in PAD
Humacyte said yesterday that it started a phase II trial of its human acellular vessel, Humacyl, as an artificial bypass graft in patients with peripheral arterial disease. The non-randomized trial is...
View ArticleClik here to view.
Abbott to close $25B St. Jude buy
Abbott (NYSE:ABT) said today that it plans to close its $25 billion buy of St. Jude Medical (NYSE:STJ) next Wednesday, Jan. 4, after receiving all necessary regulatory clearances for the deal. Abbott...
View ArticleClik here to view.
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult...
View ArticleClik here to view.
scPharmaceuticals closes $46m Series B round
scPharmaceuticals said today that it closed a $45.6 million Series B round, co-led by OrbiMed and a subsidiary of Sun Pharmaceutical Industries. Other investors included 5AM Ventures and Lundbeckfond...
View ArticleClik here to view.
Penn State researchers use immune cells to deliver cancer drugs
Researchers from the Penn State Materials Research Institute have developed a biodegradable and photoluminescent nanoparticle that are carried by immune cells to target melanoma. The team’s work was...
View ArticleClik here to view.
Appeals court upholds Patent Office’s invalidity ruling on J&J stents patent
A federal appeals court yesterday upheld a patent board decision invalidating portions of a Johnson & Johnson (NYSE:JNJ) patent covering drug-eluting stents in a case that dates back to 2009....
View ArticleClik here to view.
Scientists develop silver-releasing scaffold to prevent MRSA infection in bone
Researchers have developed a biocompatible, silver-releasing scaffold that inhibits methicillin-resistant Staphylococcus aureus, MRSA, infection in bone. The team’s work was published in Tissue...
View ArticleClik here to view.
MassDevice.com +5 | The top 5 medtech stories for January 4, 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...
View ArticleClik here to view.
Flashback Technologies wins de novo FDA nod for blood loss algorithm
Predictive data analytics company Flashback Technologies said today it won FDA de novo clearance for devices using its Compensatory Reserve Index algorithm, now cleared as an adjunctive cardiovascular...
View ArticleClik here to view.
MassDevice Q&A: Greenberg Traurig’s Lori Cohen on defending product liability...
When it comes to defending product liability lawsuits, it’s tough to top Greenberg Traurig’s Lori Cohen and her 98.3% winning percentage – she’s 57-for-58 lifetime in the courtroom.* Cohen, a...
View ArticleClik here to view.
EarlySense wants to get its mobile health sensor into your home
[Image courtesy of EarlySense]Health monitor company EarlySense is expanding into the consumer space. The Waltham, Mass.–based company announced Tuesday that is has created a contact-free consumer...
View ArticleClik here to view.
Solera Health raises $5m
Solera Health raised $5 million in a new round of equity financing, according to an SEC filing posted this week. Solera’s technology platform is designed to connect patients and physicians with...
View ArticleClik here to view.
Abbott closes $25B St. Jude buy
Abbott (NYSE:ABT) said today it closed its $25 billion buy of St. Jude Medical (NYSE:STJ), permanently tying up the 2 major medtech players. Under the merger agreement, St. Jude Medical will now be a...
View ArticleClik here to view.
Swiss Competent Authority weighs in on medical device firms “orphaned” by...
By Stewart Eisenhart, Emergo Group A second European Competent Authority, the Swiss Agency for Therapeutic Products (Swissmedic), has now addressed the burgeoning issue of medical device manufacturers...
View ArticleClik here to view.
Apligraf cell therapy changes genomic profile of chronic wound
Organogenesis Inc. said yesterday that its wound-healing cell therapy Apligraf is the 1st of its kind to significantly change the genomic profile of a treated chronic wound. The claim was supported by...
View ArticleClik here to view.
Clearside Biomedical names Beckman as new CMO | Personnel Moves, Jan. 5, 2017
Clearside Biomedical (NSDQ:CLSD) today named Dr. Richard Beckman as chief medical officer. The ophthalmologist has 13 years of clinical practice under his belt, as well as 20 years of corporate...
View ArticleClik here to view.
Sofar puts another $5m into TransEnterix
TransEnterix (NYSE:TRXC) said today that Italy’s Sofar SpA agreed to buy a $5 million stake in lieu of a $10 million milestone payment as the duo amended the $100 million deal for Sofar’s Telelap ALF-X...
View Article