5 digital health startups you need to watch in 2019
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Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).
Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Big Data Blog Business/Financial News Featured Funding Roundup Health Information Technology mHealth (Mobile Health) News Well Software / IT adheretech carepredict devotedhealth jointacademy mediktor startuphealth Source Type: news
Smith & Nephew expands robotics R & D footprint in Pittsburgh
Smith & Nephew (NYSE:SNN) is slated to open a new robotics R&D and medical education center in Pittsburgh in 2020, according to a report from the Pittsburgh Post-Gazette.
The facilities are located in the city’s Strip district, according to the report, and will triple the floor space for London-based Smith & Nephew’s robotics business, which currently employs approximately 100 individuals in the area, according to the report.
“Pittsburgh is the R&D headquarters of our rapidly expanding robotics business and we are very excited to be the first tenants at The Stacks at 3 Crossings. This state-of-the ar...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Smith & Nephew Source Type: news
Second Sight Medical releases early feasibility data on Orion cortical implant
Second Sight Medical (NSDQ:EYES) today announced preliminary results from a small feasibility study of its Orion cortical implant, which is designed to give eyesight to the blind.
Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market.
Interim data from a five-year early feasibility study, prese...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Optical/Ophthalmic Second Sight Source Type: news
DarioHealth touts updated diabetes management software
DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform.
The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said.
Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Patient Monitoring Software / IT DarioHealth Corp Source Type: news
Obalon taps Cowen to explore ‘ strategic alternatives ’
Obalon Therapeutics (NSDQ:OBLN) today tapped an advisory firm to explore “strategic alternatives,” a week after revealing plans to cut its workforce in half.
The Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, said April 3 that it would lay off 49 of its 100 employees, including all of its direct sales force, in a pivot toward retail.
Today the company said it hired investment bank Cowen “as an independent financial advisor to assist in exploring financial and strategic alternatives” to explore “a wide range of financial and strategic alternatives.&...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Mergers & Acquisitions Wall Street Beat Weight loss Obalon Therapeutics Source Type: news
Elucent Medical wins FDA nod for EnVisio breast surgery navigation device
Elucent Medical said today that it won FDA 510(k) clearance for its EnVisio surgical navigation system.
The Eden Prairie, Minn.-based company said that the EnVisio navigation system is designed for use in conjunction with the company’s SmartClip soft tissue marker during breast cancer procedures.
The SmartClip soft tissue marker is an alternative to hook-wire localization procedures used to identify malignant tissue for removal, the company said. When used with the Envisio system allows physicians to mark difficult lesions and navigate distances, depths and directions in real-time 3D during breast cancer procedures.
...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Oncology Regulatory/Compliance Surgical Elucent Medical Source Type: news
Intrinsic Therapeutics raises $52m for Barricaid annulus seal
Intrinsic Therapeutics said today that it raised $52 million in a new round of equity financing to support the U.S. commercialization of its Barricaid annulus seal.
The Boston-based company’s Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body. The device is intended as an adjunct for lumbar limited discectomy to replace missing or damaged parts of the annulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.
Intrinsic Therapeutic...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Spinal Wall Street Beat Intrinsic Therapeutics Source Type: news
Helius Medical shares tank on FDA denial
Shares in Helius Medical Technologies (NSDQ:HSDT) tanked yesterday after the company said the FDA shot down its clearance bid for the portable neuromodulation device it developed.
The Newtown, Pa.-based company’s PONS system is designed to treat neurological symptoms through electrical stimulation of nerves in the tongue. A trial of the PONS device in treating patients with chronic balance deficits from traumatic brain injuries failed to meet its efficacy endpoint in November 2017. Helius said the control group showed a significant therapeutic effect from the low-frequency pulse treatment used in that arm, skewing t...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Helius Medical Technologies Source Type: news
5 issues for medical device risk management and design controls
By Mark Leimbeck, Emergo Group
Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety.
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 - April 11, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Bedfont wins FDA nod for ToxCO carbon monoxide monitor
British medical device firm Bedfont said today that it won FDA 510(k) clearance for its ToxCO breath analysis monitor designed to measure exhaled carbon monoxide to indicate levels of CO in the blood.
The newly cleared system is intended for use in triaging cases of CO poisoning as it provides instant results at the point-of-care, the Maidstone, UK-based company said.
Samples can be taken via a low-cost mouth piece or a face mask option for patients who are either unconscious or injured, the company said. The system also automatically samples the ambient air and alarms when CO in the environment reaches a harmful level.
&#...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Respiratory bedfont Source Type: news
CMS proposes improved ambulatory BP coverage
The U.S. Centers for Medicare & Medicaid Services recently released a proposed decision memo stating that it believes there is evidence sufficient to support the use of ambulatory blood pressure monitoring for diagnosing and treating hypertension in its beneficiaries.
The agency laid out circumstances for reimbursement coverage, including white coat hypertension verified through at least two separate clinic or office visits with separate measurements three months apart or suspected masked hypertension, measured similarly.
To qualify for coverage, the devices must be quality certified and validated for use in the intend...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Centers for Medicare and Medicaid Services (CMS) Source Type: news
House members introduce companion medical device tax repeal bill
A quartet of U.S. representatives today introduced a companion bill to a Senate measure that would do away with the medical device tax altogether.
The 2.3% levy on U.S. medical device sales went into effect in 2013 but was only in place for two years before Congress put a moratorium in place. When that ended in January 2018, a second moratorium was enacted that’s due to expire at the end of this year. In 2018, the U.S. House of Representatives passed a bill to repeal the tax 283-132, but the Senate failed to act.
Last month Democratic presidential candidate Sen. Amy Klobuchar (D-Minn.) and Sen. Pat Toomey (R-Penn.) r...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Featured medicaldevicetax U.S. Congress Source Type: news
BioCardia registers for $18m offering
BioCardia (NSDQ:BCDA) has registered for an upcoming offering of its common stock, looking to raise approximately $18 millions according to an SEC filing.
The company has not yet set a price range for the offering, nor has it stated how many shares it is looking to float.
San Carlos, Calif.-based BioCardia did note the closing price of its stock on April 8 as being $1.33 per share.
The offering will include warrants to purchase additional common stock, according to the filing.
Last December, BioCardia said that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducin...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat BioCardia Source Type: news
Australia ’s TGA considering, but not yet implementing, textured breast implant ban
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods.
The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release.
The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada and ...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Oncology Regulatory/Compliance Women's Health Source Type: news
FDA warns against unapproved concussion diagnosis devices
The FDA today warned consumers against using medical devices purported to assess head injuries, saying tht only five companies are cleared to market such devices in the U.S. and that they should only be used by physicians.
“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the federal safety watchdog said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including su...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neurological Source Type: news
