Posts by rw-admin
Teva’s Digital Inhaler Now FDA Cleared
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for…
Read MoreBrainScope Receives FDA Clearance for Multi-Parameter Concussion Assessment
BrainScope, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and…
Read MoreTransEnterix Prepping for a $75M Offering
TransEnterix is planning for an upcoming $75 million offering, according to a recently posted SEC filing. The Research Triangle Park, N.C.-based company said that Stifel, Nicolaus & Company will serve as its sale agent in the offering, but the company has not yet announced how many shares it plans to float in the sale. The round…
Read MoreBoston Scientific Exercises Option to Buy Millipede for $325M
Nearly a year after bagging the option to acquire Millipede, Boston Scientific has pulled the trigger. When the pair inked the agreement in January, Boston Scientific handed over $90 million for a portion of the mitral regurgitation startup’s shares. Now, the devicemaker is paying $325 million to pick up the rest of Millipede’s shares. The deal was…
Read MoreAcorda’s Inhaled Parkinson’s Therapy Device Wins FDA Nod
Acorda Therapeutics said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s therapy,…
Read MoreFalse-Positive Mammograms Increase a Woman’s Breast Cancer Risk
Women who experience false-positive mammograms are at an increased risk of breast cancer for more than a decade, according to new research published in the British Journal of Cancer. The authors collected data from more than 1.1 million women from three population-based screening programs—one from Denmark, one from Norway and one from Spain—for the study. Patients were between…
Read MoreGE Healthcare Secretly Files for IPO
GE Healthcare reportedly filed confidentially for an initial public offering as it readies a spinout of its GE Healthcare business. The Boston-based industrial giant tapped Goldman Sachs, Bank of America, Citigroup, JPMorgan Chase and Morgan Stanley for help with the flotation, according to Bloomberg, which cited sources “who asked not to be identified as the details…
Read MoreSmith & Nephew Buys Ceterix Orthopedics for up to $105M
Smith & Nephew, the global medical technology business, today announces that it has agreed to acquire Ceterix® Orthopaedics, Inc, the developer of the NovoStitch® Pro Meniscal Repair System. This unique device addresses complex meniscal tear patterns not adequately served by other repair systems. It is highly complementary to Smith & Nephew’s leading FAST-FIX◊ 360 Meniscal Repair System, which addresses vertical…
Read MoreConMed Spending $365M on Buffalo Filter’s Surgical Technology
CONMED Corporation today announced a definitive agreement to acquire privately-held Buffalo Filter LLC (Buffalo Filter) for $365 million on a cash-free, debt-free basis. The transaction is expected to be financed through a combination of new convertible notes and an expanded and amended credit facility. The transaction is subject to customary closing conditions, including receipt of U.S.…
Read MorePeekMed Receives FDA 510(k) Clearance for Orthopedic Planning System
PeekMed® reached 510(k) clearance for its orthopedic planning system, from the U.S. Food and Drug Administration (FDA), after regulatory approval in the European Union, and successfully working with more than 1100 surgeons. Developing a product in the medical field is highly demanding when it comes to regulation.Only a few European companies achieve certification in the USA due to the detailed…
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