Clik here to view.
Medtronic launches In.Pact Admiral drug-coated balloon in Japan
Medtech titan Medtronic (NYSE:MDT) said today that it launched its In.Pact Admiral drug-coated balloon in Japan. The company won approval and reimbursement for its device last year from the Japanese...
View ArticleClik here to view.
Lessons learned: How Jeff Karp stays at the forefront of innovation
Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly. To learn about the exciting technologies emerging from Karp’s lab, join...
View ArticleClik here to view.
FDA approves first generic Epipen
The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the...
View ArticleClik here to view.
Voluntis launches upgraded insulin dosing therapeutic
Voluntis this week launched an upgraded version of Insulia, its digital therapeutic designed to give automated basal insulin dose recommendations and coaching messages for people with Type 2 diabetes....
View ArticleClik here to view.
Tandem launches insulin pump with predictive low glucose suspend feature in US
Tandem Diabetes Care (NSDQ:TNDM) last week launched its t:slim X2 insulin pump with Basal-IQ technology in the U.S. The company’s latest pump includes a predictive low glucose suspend feature designed...
View ArticleClik here to view.
Xeris Pharmaceuticals kicks off dual-hormone artificial pancreas trial
Xeris Pharmaceuticals (NSDQ:XERS) said last week that it launched a Phase I trial of its ready-to-use liquid glucagon in a closed-loop, dual-hormone artificial pancreas system. Automated insulin...
View ArticleClik here to view.
Ichor touts use of electroporation drug-delivery system in cervical cancer trial
Ichor Medical Systems said today that its TriGrid electroporation drug-delivery system was tapped for a Phase Ib/II clinical trial to administer an investigational therapeutic HPV DNA vaccine, GX-188E,...
View ArticleClik here to view.
FDA extends expiration date for swath of Mylan’s Epipens amid shortage
In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months. The move to extend the expiration...
View ArticleClik here to view.
Urotronic raises $20m for drug-coated balloon catheter
Urotronic has raised $20 million in an equity offering involving 7 investors, according to a document filed with the SEC this week. The Minnesota-based company is developing a drug-coated balloon...
View ArticleClik here to view.
Dexcom acquires diabetes management tech with TypeZero purchase
Dexcom (NSDQ:DXCM) said this week that it acquired TypeZero Technologies and its personalized diabetes management solutions. The financial details of the transaction were not disclosed. Dexcom plans to...
View ArticleClik here to view.
Valeritas launches V-Go insulin delivery device in Australia
Valeritas (NSDQ:VLRX) said today that it launched its V-Go wearable insulin delivery device in Australia. The company inked an exclusive distribution agreement in Australia with AMSL Diabetes earlier...
View ArticleClik here to view.
Tracking tumors with Precipio’s liquid biopsy tech
In the era of personalized medicine, cancer patients will often have their tumors biopsied and analyzed as doctors hunt for mutations that are driving the patient’s condition. For some forms of cancer,...
View ArticleClik here to view.
DHS warns on BD’s Alaris pump
The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker...
View ArticleClik here to view.
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid...
View ArticleClik here to view.
ALR Technologies inks Indian distribution deal for diabetes management device
ALR Technologies and Aspire Cerebro Advertising have inked a marketing deal in India for the ALRT diabetes management system. Aspira Cerebro Advertising plans to create a comprehensive marketing plan...
View ArticleClik here to view.
ivWatch wins CE Mark for continuous IV site monitor
ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through...
View ArticleClik here to view.
Inovio launches Ph1 study of Hep C vaccine
Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine...
View ArticleClik here to view.
EyeGate’s Phase 3 EGP-437 study fails to show non-inferiority
Ophthalmalogical-focused developer EyeGate Pharma said this week that the Phase 3 study of its EGP-437 delivered through its EyeGate II drug delivery system did not show non-inferiority to the...
View ArticleClik here to view.
EyePoint nabs CMS reimbursement for Dexycu cataract surgery drug
EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular...
View ArticleClik here to view.
Kaleo partners with Walgreens to offer epinephrine auto-injector
Kaleo said this week that its epinephrine auto-injector, Auvi-Q, is available at Walgreens locations across the U.S. The partnership comes as the country is dealing with a shortage of the emergency...
View Article