FDA gives nod to first newborn screening test for Duchenne muscular dystrophy
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.

FDA gives nod to first newborn screening test for Duchenne muscular dystrophy
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
Device makers not entirely out in the cold in overhaul of Stark, AKS regs
Device makers have been scrambling for space in value-based care arrangements even though the pace of adoption of those arrangements has been somewhat tepid. While device makers are not explicitly included in a proposed overhaul of the Stark and Anti-Kickback Statute (AKS) regulations, providers may soon be more engaged in these arrangements, thus providing device makers with more opportunities even if they are not included in the rewrite of the related regulatory provisions.
Insightec low-intensity focused ultrasound opens blood-brain barrier in Alzheimer’s patients
There is no FDA-approved medication for Alzheimer’s disease. But there is some hope that if the blood-brain barrier could be more easily penetrated by drug candidates they would prove more effective. That is the line of research being pursued by Israeli company Insightec Ltd. via its Exablate Neuro that provides low-intensity focused ultrasound treatment.
Dialogue’s ‘human-in-the-loop’ safety software wins CE marking
TORONTO – Montreal’s Dialogue Technologies Inc. has received class 1 CE marking for artificial intelligence (AI)-powered software that enables the company’s existing telehealth platform to reduce the time required to triage patients in emergencies. The new AI-driven Dialogue Intake software also has “human-in-the-loop” capability ensuring real-time medical intervention to verify the accuracy of information provided physicians during telehealth consultation.
Robots and telehealth drive care improvements in the Hajj
Telemedicine and robotic medicine have reshaped the provision of health care services during one of the largest annual gatherings in the world – health care that the government of Saudi Arabia provides free of charge to all pilgrims. The logistics associated with the spike in demand for health care can be daunting, but advances in medical technology have made this challenge easier.
Bioworld MedTech’s Neurology Extra for Dec. 13, 2019
Keeping you up to date on recent developments in neurology.
BioWorld MedTech Patent Highlights: Week 49
BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette.

Digital health

Caresyntax scoops up $45.6M in new financing, acquires OR analytics provider Syus
Artificial intelligence
Caresyntax GmbH, a Berlin-based provider of surgical automation, analytics and AI software technologies, picked up $45.6 million in venture funding. The funds will be used to accelerate U.S. and global expansion and support continued development and deployment of Caresyntax products. Participating...
Caris launches AI-based genomic profiling test to clarify cancer of unknown primary origin
Cancer
Irving, Texas-based Caris Life Sciences Inc. has launched an AI-based genomic profiling test to better characterize cases of cancer of unknown primary origin (CUP) and atypical cases and offer appropriate treatment options. Known as the MI GPS (Genomic Profiling Similarity) Score, the analysis is...
AI startups merge to form Vocalis, get $9M to advance vocal biomarkers for disease screening
Deals and M&A
A pair of Israeli health tech companies, Beyond Verbal and Healthymize, plan to merge to form Newton, Mass.-based Vocalis Health. The company will be focused on developing vocal biomarkers, which track voice patterns via phone calls or smart devices to screen for various voice-indicating ailments...
Current Health raises $11.5M to scale patient management tool
Financings
Current Health Ltd., of Edinburgh, Scotland, scooped up $11.5 million in a series A financing that was led by MMC Ventures. The funds are earmarked to scale up Current Health’s patient management platform, with the aim of preventing global illness in 1 million patients by 2021. Legal & General...

Financings

Imperative Care gets $85M to market aspiration-based devices to treat a broader range of stroke
Cardiovascular
The mechanical removal of clots from the brain has become increasingly standard in ischemic stroke cases. Last year, the American Heart Association/American Stroke Association guidelines expanded the recommended window for its use up to 24 hours an event. Aspiration-based device stroke treatment startup Imperative Care Inc. has now raised an $85 million series C round to back the marketing of two recently cleared products on this front.

Newco news

Matricelf wins SEED AWARD with 3D printing heart design
Cardiovascular
HONG KONG – Matricelf Ltd., an Israeli medical 3D printing company based in Tel Aviv, has won a SEED AWARD and the ¥1 million (US$143,000) that goes with the prize. The Global Final of the SEED AWARD 2019 was held in Shenzhen, China. The organizer Seedland Group, China’s leading real estate company...

China’s Genskey raised $14M in series B to advance pathogen testing
Financings
BEIJING – Infection diagnostics specialist Genskey Technologies Co. Ltd., of Beijing, closed a series B financing round to secure ¥100 million (US$14 million) to advance pathogen testing using next generation sequencing. The series B round was joined by SB China Capital, Shanghai Lin Chong...
Righteye wins breakthrough device designation for Parkinson’s test
Neurology/Psychiatric
The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in...

Deals and M&A

Enzyre, Takeda team up to develop home diagnostic device for hemophiliacs
Diagnostics
LONDON – Dutch startup Enzyre BV is teaming up with Takeda Pharmaceutical Co. Ltd. to complete development of a home diagnostic device that aims to make it as easy for hemophiliacs to self-test their coagulation status as it is for diabetics to monitor their blood sugar levels.
Lantheus expands microbubble, cancer applications with Carthera collaboration
Collaboration
Lantheus Holdings Inc., of North Billerica, Mass., has entered a strategic collaboration with Paris-based Carthera SAS for the use of its microbubbles in combination with Carthera’s investigational Sonocloud system. The implantable device is in development for the treatment of recurrent glioblastoma, a fast-growing brain tumor with a post-diagnosis median survival of just 15 months. The new deal furthers two of Lantheus’ strategic goals, finding new applications for its microbubbles and expanding its footprint in oncology.
GE enters 3D bioprinting partnership with ASLS
3D printing
LONDON – GE Healthcare Life Sciences is bringing its heft to 3D bioprinting in an agreement with Advanced Solutions Life Science Inc. (ASLS), in which the partners aim to automate the production of quality-assured, vascularized tissues, for bone, soft tissue and organ replacements.
Viewray sees an additional $139M with collaborations with Elekta, Medtronic
Collaboration
As part of newly announced collaborations with Cleveland-based Viewray Inc., Elekta AB assumed a 9.9% stake in the company, and Medtronic plc also made a minority investment. The company's largest shareholder, Fosun International Ltd., also led the round. "In total, the company raised approximately $139 million, net of fees," Viewray President and CEO Scott Drake told BioWorld MedTech.
Veracyte seeks wider diagnostics footprint with Nanostring licensing deal
Diagnostics
Genomic testing firm Veracyte Inc., of South San Francisco, has inked a definitive agreement with Seattle-based Nanostring Technologies Inc. for the global rights to Nanostring’s Ncounter platform. The deal – for $50 million in cash and Veracyte stock, plus up to $10 million in potential milestone payments – will allow Veracyte to develop and commercialize diagnostic tests on Nanostring’s Ncounter Flex system.

Europe

Scientists create artificial neurons capable of mimicking biological counterparts
Science
LONDON – Scientists in the U.K. are claiming a world first, after successfully reproducing the electrophysiology of biological neurons in silicon chips. It is said that artificial neurons respond to non-linear physiological feedback in real time, in exactly the same way as their biological counterparts. Crucially, in terms of their use in medical implants, the analogue chips have a power consumption 10⁹ times lower than equivalent digital microprocessors, which other attempts to make synthetic neurons have used.

Asia-Pacific

China striving to catch up in med-tech innovation for heart diseases
Cardiovascular
BEIJING – While acknowledging that China still needs to play catch up in med-tech innovation, Chinese cardiovascular experts are striving to make breakthroughs in bioabsorable stents and transcatheter heart valves with government-backed research projects underway.

FDA gives thumbs up to Cochlear’s implantable bone conduction hearing system
Ear, Nose and Throat
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
Australian researchers create kidney tissue from iPS cells
Science
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. For more than two decades, Melissa Little and her team at Murdoch have investigated the molecular and cell development basis of kidney...

Clinical

Israeli, U.S. teams collaborate on technology for respiratory tract diseases
Respiratory
HONG KONG – Negev-based Ben-Gurion University (BGU) and Beersheba-based Soroka Medical Center in Israel, working with the Cincinnati Children's Hospital Medical Center and the University of Cincinnati (UC), have developed a technology for unblocking and removing secretions from airways to to treat patients with diseases affecting the respiratory tract.
Boston Sci’s Watchman scores well at 50 months for hemorrhagic stroke
Cardiovascular
The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device.
Study bolsters case for stenting over bypass in long femoropopliteal lesions
Drug eluting stent
The recent controversy over the use of paclitaxel in the peripheral vasculature has clouded the larger debate over whether bypass is superior to endovascular therapies for the lower limbs. However, a new study suggests that nitinol stents provide a feasible alternative to bypass even for lesions of the femoropopliteal artery that are 30 cm in length.
High adherence seen with Digimeds in difficult to treat HCV patients
American Association for the Study of Liver Diseases
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
Mologic begins recruitment of COPD urine-based home test
Respiratory
LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.
Study supports long-term performance of Senseonics’ Eversense CGM
Diabetes
Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.

BioWorld MedTech Perspectives

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...
Substantial equivalence revisited
BioWorld MedTech
When things go awry, we often hear the rather dubious claim that goes something like this: "I hate to say I told you so, but..." Truth be told, that's...

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