Biotronik launches PK Papyrus covered coronary stent
Biotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S.
When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs performed in the U.S. require a covered stent, according to Lake Oswego, Ore.-based Biotronik, qualifying PK Papyrus for a humanitarian device exemption.
“The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology,” president Ryan Walte...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Stents Biotronik Source Type: news
Bio-Rad loses bid to re-hear $8m loss to former GC
The U.S. Court of Appeals for the Ninth Circuit late last month shot down a bid from Bio-Rad Laboratories(NYSE:BIO) to rehear a decision to affirm a loss to a former general counsel in a whistleblower retaliation suit, according to recently released court documents.
Bio-Rad and its CEO had appealed a jury verdict in favor of former GC Sanford Wadler in which he alleged that the company terminated his employment after he blew the whistle on allegations that the company violated the Foreign Corrupt Practices Act in China.
A jury later ruled in Wadlers favor, finding that Bio-Rad violated the Dodd-Frank Act and the Sarbanes-O...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Legal News Bio-Rad Source Type: news
Admedus deals vaccines biz to Constellation Therapeutics
Admedus (ASX:AHZ) said today that it agreed to sell its vaccines business to Constellation Therapeutics in a deal that will see it own nearly 30% of the Chinese company.
Other shareholders in the vaccines would own another 11%, Queensland, Australia-based Admedus said. Sun Bright Holdings will own the remainder and put in $18 million until November 2022, in five $3.6 million installments pegged to “certain milestones,” the company said. Failure to pay an installment would trigger the conversion of 12% of Constellation shares to the Admedus bloc of vaccine business shareholders. Admedus CEO Wayne Patterson is ...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Regenerative Medicine Wall Street Beat Admedus Ltd. Source Type: news
Angel Medical ’ s Guardian implantable heart monitor fails on efficacy endpoint
A clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks.
Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without ...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Featured Angel Medical Systems Inc. Source Type: news
FTC grants final approval for Fresenius ’ s $2B buyout of NxStage
The U.S. Federal Trade Commission said yesterday that it granted a final order of approval to Fresenius Medical Care (NYSE:FMS; ETR:FRE) for its $2 billion acquisition of NxStage Medical.
The approval came with a caveat that the companies divest their assets and rights to research, develop, manufacture, market and sell NxStage’s bloodline tubing sets intended for use during hemodialysis treatment.
To mollify the anti-trust regulators, NxStage last July agreed to deal its Medisystems bloodlines business to B. Braun.
The final order was approved in a three-to-two vote, according to an FTC posting.
The $30-per-sha...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Dialysis Featured Mergers & Acquisitions Wall Street Beat Fresenius NxStage Medical Inc. Source Type: news
Avinger wins FDA nod for Pantheris SV small vessel atherectomy device
Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system.
The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%.
The newly cleared device features a lower profile and longer length than the standard Pantheris, and is indicated for diagnosing and treating peripheral artery disease in small vessels between 2mm and 4mm.
“We are excited to receive U.S. pre-marketing clearance for Panther...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Vascular Avinger Source Type: news
Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.
Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.
Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news
FDA identifies hundreds of device types affected by sterilization facility closures
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year.
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 10, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
ReWalk Robotics raises $4m
ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.
In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.
Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.
The company is looking to raise an additional appro...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Wall Street Beat ReWalk Robotics Source Type: news
Varian Medical joins embolic therapy tech dev ABK Biomedical ’ s $30m Series B
Varian Medical (NYSE:VAR) has joined a $30 million Series B round of financing for embolic therapy tech developer ABK Biomedical.
Palo Alto, Calif.-based Varian Medical Systems led the round alongside F-Prime Capital, Halifax, Nova Scotia-based ABK Biomedical said.
“ABK has a unique approach to address a large unmet need for patients with non-resectable liver tumors. This technology is aligned with our goal of delivering innovative solutions in cancer care,” Varian strategy & biz dev VP Gregory Sorensen said in a press release.
“We are impressed with the ABK Biomedical team and believe the company ha...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Oncology Radiosurgery/Radiation therapy Wall Street Beat abkbiomedical Varian Medical Systems Source Type: news
Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018
Medtronic (NYSE:MDT) said that it named Sean Lennon as its new chief information officer, set to take effect April 29.
The Fridley, Minn.-based medtech giant said that Lennon will take over for Mike Hedges, who is retiring from the position after 19 years with Medtronic, including 10 as CIO.
Prior to joining Medtronic, Lennon served as CIO with Allergan (NYSE: AGN), the company said. He has previously held senior leadership positions with pharmaceutical companies including Watson/Actavis, Novartis (NYSE:NVS) and Schering-Plough.
Clearside Biomedical appoints Lasezkay as interim CEO
Clearside Biomedical (NSDQ:CLSD) s...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Allergan Clearside Biomedical ICU Medical Inc. iHear Medical LifeScan Inc. lumenxt Medtronic Novartis OptiScan oregonbioscienceassociation Owens & Minor Shape Memory Therapeutics SynCard Source Type: news
Synchron ’s thought-to-text tech starts clinical trial
Synchron’s Stentrode technology is designed to restore communication to people with paralysis. (Image from Synchron)
Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.
The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications technologies.
Stentrode was designed to be small and flexible enough to safely pass through curving blood vessel...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Bioelectronic Medicine Clinical Trials Featured Neurological News Well Research & Development DARPA Synchron U.S. Department of Defense Source Type: news
Epitomee Medical raises $8m for novel weight-loss device
Early-stage medical device developer Epitomee Medical said today that it raised $8 million in a new round of equity financing to support its novel Epitomee Capsule “shapeshifting” pill intended to prevent diabetes and promote weight loss.
The Israel-based company said that its Epitomee Capsule contains a shape-shifting scaffold that, after it is ingested, helps the body have an early sensation of fullness and prolonged gastric emptying through direct mechanosensory stimulation.
The pills are designed to be taken twice a day to lower caloric intake and promote weight loss, Epitomee Medical said.
“The Epito...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Wall Street Beat Weight loss epitomeemedical Source Type: news
Morgan Stanley: Apple ’ s mHealth play could triple entire mobile market
Though Apple (NSDQ:AAPL) has only begun to step into the healthcare market, a group of Morgan Stanley analysts estimate the company’s opportunity in the U.S. healthcare market to be three times larger than the global smartphone market, according to a Bloomberg report.
The analysts estimated that Apple’s healthcare market opportunities could be worth between $15 billion up to a massive $313 billion by 2027, according to the report.
The Cupertino, Calif.-based tech giant’s massive ecosystem built around the iPad and iPhone, other iOS devices and its App Store could allow Apple to disrupt “various processes i...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured mHealth (Mobile Health) Wall Street Beat Apple Source Type: news
The Nuremberg Code and its impact on clinical research
by Natalie Jarmusik, Clinical Research Associate, IMARC Research
The Nuremberg Code is one of the most influential documents in the history of clinical research.
Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects.
We’ll take a closer look at its origins, its guidelines and its enduring impact.
What Is the Nuremberg Code?
When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945. As part of the Tribunal, a series of trials were he...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
