Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U. The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive […]
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TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms
TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause. The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule. Shares in TherapeuticsMD fell earlier this month after the company announced that the FDA accepted its resubmitted […]
How this biotech plans to go up against big pharma with its eye disease products
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out. “There’s […]
Integrity Applications inks exclusive Dutch distro deal for GlucoTrack
Integrity Applications said today it inked an exclusive distribution deal with MediReva B.V. to distribute its GlucoTrack non-invasive glucose measuring device in the Netherlands, effective December 22. Integrity Application’s flagship GlucoTrack is a sensor that clips to the earlobe and uses a combination of metrics to determine blood glucose based on physiological changes in the body. […]
Spectral Medical wins FDA nod for Spectral Apheresis Machine
Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange. The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver […]
Beta Bionics raises $2m
Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. The company is […]
Anika Therapeutics wins FDA nod for bone void filler
Anika Therapeutics (NSDQ:ANIK) said today that it won 510(k) clearance from the FDA for its hyaluronic acid-based bone void filler The indication covers filling bone voids or defects that aren’t intrinsic to the stability of the bone, created during surgery or the result of traumatic injury. Made of a synthetic, biocompatible bone graft substitute material, […]
Nanobiotix’s nanoparticle-immunotherapy trial wins FDA approval
Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody. The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and […]
SEC subpoenas Ocular Therapeutix over pain relief implant
Ocular Therapeutix (NSDQ:OCUL) revealed last week that it received a subpoena from the Securities and Exchange Commission dated Dec. 15, requesting information about the company’s post-surgical pain relief implant, Dextenza, which was rejected by the FDA earlier this year. The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the […]
Medtech stories we missed this week: Dec. 22, 2017
From Hepa Wash’s new collaboration to Stimwave’s FDA clearance, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Hepa Wash collaborates with GALS program Hepa Wash announced in a Dec. 7 press release that it has collaborated with the German Accelerator Life Sciences (GALS) program to expand its […]