5 Wearable Technologies Conference exhibitors you should know
The 34th edition of the Wearable Technologies Conferenceseries is taking place today and tomorrow in San Francisco. Co-located with Semicon West, the Wearable Technologies Conference offers a number of panels to discuss wearables in healthcare and IoT, as well as conference exhibitors and networking opportunities. Here are five companies touting their latest wearable technologies at this year’s conference. Next >> (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics mHealth (Mobile Health) Pain Management Patient Monitoring Software / IT Accumold CareWear datwyler Multek Varta Source Type: news
UL to close up notified body shop ahead of Brexit
The U.K.’s pending secession from the European Union prompted UL International to start closing up shop as a notified body for medical device approvals. British voters in June 2016 approved withdrawing from the E.U. on a 51.9% to 48.1% vote. An initial Brexit deadline of March 29 was broken after Parliament voted three times to reject deals brokered with the E.U., raising the specter of a unilateral “no-deal” Brexit before the newest deadline of Oct. 31. Get the full story at our sister site, Medical Design & Outsourcing (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Regulatory/Compliance Wall Street Beat UL International Source Type: news
DaVita, Fresenius slide on Trump threat to overhaul dialysis market
Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit today after a report surfaced that the Trump administration is readying an overhaul of the kidney treatment market. The president plans to issue an executive order tomorrow that would seek to incentivize kidney transplants and home hemodialysis in a bid to lower the federal government’s annual $100 billion kidney care tab, Politico reported, citing “two individuals with knowledge of the announcement.” The strategy involves new payment models from the U.S. Health & Human Services Dept. designed to move patien...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Featured Wall Street Beat DaVita Inc. Dept. of Health & Human Services (HHS) Fresenius Source Type: news
Cutera snags Vyaire Medical ’ s Mowry for CEO | Personnel Moves, July 9, 2019
Cutera (NSDQ:CUTR) said today that it snagged Vyaire Medical CEO David Mowry to be its new CEO, effective immediately. The aesthetic device maker in January fired president & CEO James Reinstein after the company missed expectations for its 2018 top line, naming COO Jason Richey as interim chief executive. Mowry led Tornier to a $3.3 billion merger with Wright Medical in October 2015. After leaving the COO role at Wright the next year, he was tapped to lead Vyaire Medical, a rollup of four respiratory businesses BD acquired in the March 2015 deal for CareFusion. Initially a joint venture partner in Vyaire with private...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Camstent Cerner Corp. Cutera Inc. Dentsply Sirona Inari Medical Medline Industries Inc. Neuronetics Ocular Therapeutix Personnel Moves Pfizer Pure Bioscience Source Type: news
FDA approves ConTIPI Medical ’ s ProVate pelvic organ prolapse treatment
ConTIPI today announced FDA approval for its ProVate device. ProVate is designed to treat pelvic organ prolapse in women. It’s a disposable, non-invasive treatment option that supports lateral vaginal walls and mechanically prevents cervical/vault descent, according to the company. It blocks further descent of the anterior/posterior walls within its central piece and is available in six different sizes. “For many years we have been working to promote pelvic floor solutions and products that will help every woman conduct a normal life and fully control her medical condition,” founder and CEO Elan Ziv said ...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) Women's Health ConTIPI Source Type: news
Fresenius invests in BioIntelliSense
Fresenius Medical Care (NYSE:FMS; ETR:FRE) today announced an investment in BioIntelliSense for an undisclosed amount. Denver-based BioIntelliSense is developing a medical-grade data services platform for continuous remote health monitoring, predictive analytics and algorithmic clinical insights. Through the agreement, Fresenius will use the advanced analytics and artificial intelligence to develop medical wearables for clinical pathways that allow clinicians to be alerted for early intervention of medical conditions. The company says the combination of the two technologies can help prevent complications and reduce unnece...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics Dialysis Fresenius Fresenius Medical Care Source Type: news
AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. These include robust axonal outgrowth, myelination of human stem cell-derived neurons by primary human Schwann cells, and evaluation of nerve conduction velocity, according to the New Orleans-based company. Get the full story on our sister...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Neurological Research & Development Stem Cells axosim Source Type: news
Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle conjugates designed to seek out and eliminate cancer cells. Get the full story at our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Drug-Device Combinations Optical/Ophthalmic Research & Development Aura Biosciences Clearside Biomedical Source Type: news
Australia regulators publish guidance on recognized QMS standards
By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news
Inspire Medical scores reimbursement win from UnitedHealth
Inspire Medical Systems (NYSE:INSP) logged another reimbursement win, this time with the nation’s largest private insurer, UnitedHealth. Minneapolis-based Inspire makes an eponymous device designed to treat obstructive sleep apnea using hypoglossal nerve stimulation. UnitedHealth has about 41 million lives under coverage, Inspire said. “We are very pleased to receive this positive coverage decision from UnitedHealthcare. As health plans continue to update their coverage policies to include Inspire therapy, an increasing number of patients and physicians will have access to our innovative therapy,” preside...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Neuromodulation/Neurostimulation Respiratory Wall Street Beat Inspire Medical Systems Inc. Reimbursement UnitedHealth Group Source Type: news
Strata Skin Sciences inks Korea distribution deal
Strata Skin Sciences (NSDQ:SSKN) today announced a new Korean direct distribution deal with Kosmo Meditech for direct capital sales and direct recurring revenue sales in Korea. Kosmo Meditech has worked with Strata Skin Sciences for more than 13 years. The deal with help strengthen Strata’s Xtrac excimer laser value proposition in Korea and expand its installed base of over 250 devices in the country, according to the company. “We have been a proud partner in the Xtrac business in Korea for over 13 years and are very happy to be the first international launch partner of Strata’s recurring business model....
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Distribution Kosmo Meditech Strata Skin Sciences Source Type: news
Agiliti snags Zetta Medical
Healthcare technology management firm Agiliti said it acquired Zetta Medical Technologies for an undisclosed amount. Lake Zurich, Ill.-based Zetta offers engineering services, parts and pre-owned medical imaging equipment via a network of OEM trained-engineers, according to Minneapolis-based Agiliti, formerly known as Universal Hospital Services. “Zetta’s specialized capabilities and technical expertise are an ideal complement to our expanding platform of clinical engineering services,” CEO Tom Leonard said in prepared remarks. “This acquisition builds upon our outsourced and supplemental biomedical...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Imaging Mergers & Acquisitions Wall Street Beat Agiliti Zetta Source Type: news
Medeon invests in ortho, urologic companies
Medeon Biodesign (TPEx:6499) said today that it recently led and closed investments in an orthopedics startup and a company whose device was designed to treat benign prostatic hyperplasia (BPH). Panther Orthopedics is a Silicon Valley startup working on fixation solutions for orthopedic extremity applications. Prodeon is a Taiwan-based company offering a simple, office-based treatment option for BPH patients who are seeking immediate relief from lower urinary tract symptoms (LUTS). Panther Orthopedics’ FDA- 510(k) cleared Puma System is designed to treat orthopedic injuries with the benefits of screws and flexible ...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Funding Roundup News Well Orthopedics Urology Wall Street Beat Medeon Biodesign pantherorthopedics Prodeon Source Type: news
FDA clears Biotronik ’ s third-gen injectable cardiac monitor
Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor. Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T scans. “Receiving FDA clearance on Biomonitor III further demonstrates Biotronik’s continued dedication to designing innovative technology solutions that improve patient lives,” president Ryan Walters said in prepared remarks. “This device mainta...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance Biotronik Source Type: news