Alydia Health wraps up enrollment in pivotal study of device postpartum hemorrhage
Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage. The company expects to see the publication of results by year-end.

Alydia Health wraps up enrollment in pivotal study of device postpartum hemorrhage
Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage. The company expects to see the publication of results by year-end.
Researchers develop diagnostic system that detects up to 40 infectious respiratory pathogens in one test
BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour.
Advamed questions EPA methodology for risk associated with ethylene oxide
The response from industry regarding the Environmental Protection Agency’s (EPA) draft rule for ethylene oxide (EtO) varied considerably, but the Advanced Medical Technology Association (Advamed) argued a fundamental methodological point in its comments to the docket. Advamed’s Ruey Dempsey said the EPA approach to determining safe levels of EtO relies on “a single epidemiological study,” an approach Dempsey said has drawn fire from the National Academies of Science.
Today's news in brief
BioWorld MedTech's briefs for Feb. 14.
Surgeons carry out first robotic supermicrosurgery
LONDON – Surgeons in the Netherlands have carried out what is claimed as the first human supermicrosurgery, connecting vessels of a diameter as low as 0.3 mm using a purpose-designed robotic system.
Surgeons come together to create Field Orthopaedics to address market shortcomings
PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.
Med-tech gainers and losers for Feb. 10-14, 2020
The top 10 med-tech stock gainers and losers for the week.
BioWorld MedTech’s Neurology Extra for Feb. 14, 2020
Keeping you up to date on recent developments in neurology, including: PTSD linked to a dysfunction of the brain networks that control memory; Molecule offers hope for halting Parkinson's; Brain abnormalities associated with schizophrenia in individuals with 22q revealed.
Holiday notice
BioWorld's offices will be closed in observance of Presidents Day in the U.S. No issue will be published Monday, Feb. 17.

Digital health

Medtronic acquisition aims to increase precision, predictability in robotic surgery
Deals and M&A
Dublin-based Medtronic plc acquired privately held Digital Surgery, which is focused on surgical artificial intelligence (AI), data analytics, and digital education and training. The companies did not release the terms of the deal. Medtronic plans to integrate Digital Surgery’s AI technology into...
Phone apps not apt for cancerous skin lesion detection and monitoring
Artificial intelligence
LONDON – Consumer smartphone apps that use image processing algorithms to assess and monitor potentially cancerous skin lesions have not been properly tested in clinical trials and cannot be relied on to produce accurate results, according to a systematic review of published studies.
Panel dials down the hype around AI to focus on its promise
Artificial intelligence
ANAHEIM, Calif. – Is artificial intelligence (AI) ready for prime time in health care? What’s hype and what’s real? That’s the question that was posed to an expert panel at MD&M West.
Keeping pace with the digital revolution while searching for value
Conferences
ANAHEIM, Calif. – The digital health wave is impacting seemingly every aspect of health care, from digital therapeutics where software is the therapy to powerful analytics that bring actionable insights to aid in a clinical situation.

Financings

Cloudcath raises $12M to back at-home peritoneal dialysis monitoring
Series A
San Francisco-based startup Cloudcath has raised a $12 million series A round to support commercialization of its first product that enables remote, real-time monitoring for at-home peritoneal dialysis patients. The expectation is that the notifications it offers to health care providers will enable earlier intervention to avoid complications, including infection. The Cloudcath system is pending U.S. FDA clearance.

Newco news

Orpyx unveils sensory insoles to better predict dangerous diabetic foot ulcers
Diabetes
TORONTO – Calgary, Alberta-based Orpyx Medical Technologies Inc. has launched a sensory insole with remote patient monitoring to prevent potentially fatal diabetic foot ulcers (DFU) and neuropathy-related ulcers. According to Orpyx CEO Breanne Everett, development of the Orpyx SI sensory insole...

Arpeggio Bio nabs $3.2M to advance nascent RNA drug screen
Financings
Boulder, Colo.-based startup Arpeggio Biosciences Inc. scooped up $3.2 million in seed funding in a round led by Khosla Ventures, with participation by Fundersclub, Fifty Years, TechU and Y Combinator.
Company designs glove to replace echocardiography device
Cardiovascular
BOGOTA, Colombia – A startup in Mexico has developed an intelligent glove to diagnose cardiac diseases in seconds just by touching a patient’s chest. The invention could become available on the market by the end of 2020, when Soluciones Kenko, from Jalisco, Mexico, expects to hit the Mexican market...

Deals and M&A

Inex inks deal for IVD kit in Taiwan
Diagnostics
HONG KONG – Singapore molecular diagnostics group Inex Innovate Pte. Ltd. has inked a deal to have its in-vitro diagnostic (IVD) kit for the detection of ovarian cancer distributed in Taiwan. The value of the deal with the New Taipei City, Taiwan-based electronics and med-tech distributor Inalways Corp. is subject to annual minimum order quantities and milestones in relation to regulatory approvals.
M&As and deals up overall in 2019 for med tech, an investor haven in 2020
Analysis and data insight
Last year’s robust deal-making environment, high-value M&As, increasing financings and a supportive public market has set the stage for continued med-tech enthusiasm among investors and partners in 2020.
3D Systems and Collplant Biotechnologies construct new partnership
Collaboration
3D Systems Inc., of Rock Hill, S.C., and Rehovot, Israel-based Collplant Biotechnologies Ltd. have established a blueprint for their collaboration to develop tissue and scaffold bioprinting processes.
Masimo to buy Nanthealth’s connected care business, provides estimates for 2020 guidance
Digital health
Irvine, Calif.-based Masimo Corp. has agreed to buy the connected care assets of Nanthealth Inc., of Culver City, Calif., for a $47.25 million up-front cash payment. In addition, Masimo provided estimates for its full-year 2020 financial guidance, saying product revenue will increase to $1.035 billion, which reflects reported growth of 10.6% to 10.9%. The transaction is expected to close in the first quarter of the year, subject to customary closing conditions. In addition, Masimo expects to fund the acquisition with existing cash on hand.
Sebacia names CEO, picks up Sienna assets
Aesthetics
Duluth, Ga.-based Sebacia Inc., which is focused on dermatology and aesthetics, has introduced its new CEO and reported the acquisition of all assets related to Sienna Biopharmaceuticals Inc.'s silver photoparticle technology, which is being reviewed by the FDA for light hair removal.

Europe

Novacyt launches test for new coronavirus
Diagnostics
As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses.

Asia-Pacific

Argentina ramps up production of face masks as Chinese demand surges
China
BOGOTA, Colombia – Medical supply manufacturers in Argentina have seen a surge in demand for their products from China, which is reaching out globally for the goods it needs to deal with the outbreak of COVID-19.

Coronavirus-related panic purchases trigger supply chain disruptions
Infection
HONG KONG – The recent coronavirus (2019-nCov) scare has led to a rush of demand for masks that could soon strain pharmaceuticals and med-tech companies alike. In Hong Kong, queues for surgical masks now snake around the block.
Hong Kong researchers create fastest coronavirus diagnostic test to date
Diagnostics
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the...

Clinical

Pan-Cancer Project looks closer, sees more
Science
LONDON – The genomes of 38 different tumor types and the 47 million mutations that fostered their growth are revealed in unprecedented detail in 23 studies published in Nature and other journals on Feb. 6, 2020.
Soliton sees positive data from study of fibrotic scars
Aesthetics
Soliton Inc., of Houston, unveiled positive proof-of-concept (POC) study results out to 12 weeks using its Rapid Acoustic Pulse (RAP) device for the treatment of fibrotic scars. Overall, the treatment of fibrotic scars using the device proved safe and tolerable during this POC study.
Biotime streamlined as Lineage came, thaw, conquered in dry AMD cell therapy
Ocular
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that “people had wondered why [enrollment] was slow” in the company’s dry age-related macular degeneration (AMD) phase I/IIa trial – it was for safety reasons – and concerns about the pace were alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed.
New pilot study of Medtronic’s Symplicity Spyral to test targeted approach
Nephrology
Years after a setback to its clinical program, Medtronic plc‘s Symplicity brand renal denervation (RDN) system appears to be firing on all pistons. The Dublin-based company said this week that it will begin enrolling patients in a pilot study to assess the safety and efficacy of its newer-generation Symplicity Spyral using a targeted procedural approach with fewer radiofrequency (RF) ablations.
Abbott gets OK to study Amplatzer Amulet for AF patients who face stroke risk
Cardiovascular
The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.
GI Dynamics enrolls first patient in pivotal Endobarrier trial
Diabetes
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.

BioWorld MedTech Perspectives

The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR; bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...
FDA’s new man of regulatory mystery
BioWorld MedTech
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American...
Scott Gottlieb and the FDA’s revolving door problem
BioWorld MedTech
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the...
Four “Spooky” ways to fix the 510(k) dilemma
BioWorld MedTech
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot...

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