Report: Apple hiring dozens of MDs, solidifies venture into healthcare

Apple Health

Apple (NSDQ:AAPL) has hired dozens of medical doctors for positions with various teams at the company, confirming its plans to move into the healthcare biz, according to a recent CNBC report.

Many of the hires have been under the radar, according to the report, which estimates the company has more than 40 and up to 50 doctors on its roster.

The move suggests that Apple may be looking to integrate more health technologies into its platforms, and that it could be looking to branch out into applications for people with specific serious medical conditions and not focus as much on general wellness, CNBC reports.

The medical professionals are influential, according to the report, and are scattered across a number of teams to guide strategy as the tech giant continues to develop for the healthcare market.

Apple hired orthopedic surgeon Sharat Kusuma to manage its partnership with Zimmer Biomet (NYSE:ZBH) as the company explores whether its tech platform can help patients recover from hip and knee surgeries, according to CNBC.

The hires may also help the company deflect criticism, such as the scathing New York Times article criticizing the company’s electrocardiogram-equipped next-gen Apple Watch, and win over the medical community, according to the report.

While many of the doctors the company has hired are working on the Apple Watch, others are working with the health records group and some are employed to treat employees at the company’s headquarters, according to CNBC.

Many of the doctors also have connections to execs at the company, the report indicates. Former Stanford Medicine doctor Sumbul Desai works closely with Apple COO Jeff Williams, according to the report, while Dr. Bud Tribble is a software VP at the tech giant and an original member of the Macintosh design team.

Other notable medical members include family medicine doctor Mike Evans and anesthesiologist Michael O’Reilly, who’s been at the Cupertino, Calif.-based company for six years, CNBC said.

Many of the doctors employed by Apple are still seeing patients, according to the report, which CNBC theorizes could “give Apple an edge by emphasizing the patient experience.”

In November, an atrial fibrillation screening study using Apple’s next-gen Apple Watch enrolled 400,000 subjects, making it the largest study of its kind to date.

The post Report: Apple hiring dozens of MDs, solidifies venture into healthcare appeared first on MassDevice.

Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal

Edwards Lifesciences, Bay Labs

Edwards Lifesciences’ (NYSE:EW) and  cardiovascular artificial intelligence medtech firm Bay Labs, have inked a multi-faceted collaborative cardiovascular-focused development deal, Bay Labs said today.

San Francisco-based Bay Labs said that the partnership involves multiple initiatives including the development of new AI-powered algorithms in Bay Labs’ EchoMD software suite and the integration of EchoMD algorithms into Edwards’ CardioCare quality care navigation platform, as well as support for ongoing clinical studies.

“Our vision is to improve patient care throughout the continuum from disease detection to appropriate intervention. Working with Edwards to deploy Bay Labs’ AI software with deep learning technology into clinical settings has the potential to derive quality improvements and to increase the accuracy of timely heart disease detection,” Bay Labs co-founder & CEO Charles Cadieu said in a prepared statement.

Bay Labs said that it has already integrated EchoMD algorithms into the CardioCare platform for investigational use to “retrospectively analyze echocardiograms,” and added that it believes that integration of the existing and future algorithms could improve quality and increase heart disease detection.

“It is unfortunate that patients suffering from severe aortic stenosis frequently do not receive a proper diagnosis, for a variety of reasons. The value of Bay Labs’ technology is in providing help for these patients to be appropriately diagnosed and successfully find their way to proper treatments,” Edwards strategy & corp dev corporate VP Don Bobo said in prepared remarks.

Earlier this month, Edwards Lifesciences launched a pivotal trial of its Pascal mitral valve repair system, with the first procedure being performed at Atlantic Health System’s Morristown Medical Center.

The post Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal appeared first on MassDevice.

Bruin Biometrics lands second SBIR award for ortho device

Bruin Biometrics (BBI) said it has won a $1.4 million Small Business Innovation Research (SBIR) Phase II program award from The National Institute of Arthritis and the musculoskeletal and skin division of the National Institutes of Health.

BBI (Los Angeles) uses biometric sensor technology to aid clinicians in the early detection and monitoring of chronic, preventable conditions. The award will help advance the detection capabilities, design and clinical evaluation of the company’s OrthoSonos, a novel acoustic emission device for orthopedics.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Bruin Biometrics lands second SBIR award for ortho device appeared first on MassDevice.

Vapotherm touts automated oxygen controller in preemie study

VapothermA recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range.

The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % for manual control alone, the company said in a statement. The study was published in the Archives of Disease in Childhood: Fetal and Neonatal Edition.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Vapotherm touts automated oxygen controller in preemie study appeared first on MassDevice.

Report: Medtech R&D looking to diversification, non-traditional partners to handle hurdles in innovation

heart - generic

Portfolio diversification, improving time to market and the use of real-world evidence are top priorities amongst R&D leaders at medtech companies, according to data from a new survey.

Investigators in the survey, performed by Deloitte and AdvMed, were looking to explore challenges R&D leaders face in medtech and how they are responding to shifts throughout the industry.

The report includes responses from research and development leaders at 22 mid-sized and large medtech companies, surveyed between April and August this year. The survey included questions on R&D investments, sources of innovation, regulatory impacts and other priorities and challenges, Deloitte wrote in the report.

Of the executives surveyed, 86% said that portfolio diversification tops their priorities for handling a “need to drive innovation, improve margins and reduce cost.” A total of 82% reported accelerating time to market as a priority, while 77% said that leveraging real-world evidence in product development was a top concern.

Only 64% and 55% of respondents indicated that developing digitally enabled solutions and software and improving product quality or reducing risk were priorities, respectively.

Medtech may be looking more to nontraditional partners, including tech and healthcare companies, to drive their innovation, Deloitte reports. Eighty-two percent of companies surveyed said they plan to seek such collaborations over the coming years, almost double the current 42%.

Increasing complexity amongst global regulatory bodies was identified by 95% of respondents as a top challenge for R&D leaders over the next three to five years, while 64% of respondents said that regulatory complexity was affecting new product development decisions.

New payment models are contributing significantly to shifts in R&D focus according to the report. Sixty-eight percent of respondents said that they changed their focus on innovation due to “payment model and care delivery reforms.”

While 100% of those surveyed said that they were investing in device connectivity, 77% said that data integration in new technology was a “key challenge,” according to the report.

In response to the challenges, a total of 73% of those surveyed said they are adopting hybrid operating models that combine centralized and decentralized resources, according to Deloitte.

The post Report: Medtech R&D looking to diversification, non-traditional partners to handle hurdles in innovation appeared first on MassDevice.

‘Breakthrough’ eye-pressure sensor trial begins in Germany

(Image courtesy of Implandata)

Implandata Ophthalmic Products announced that the first patient in its international, multi-center, ARGOS-SC01 clinical study has been successfully implanted with its novel pressure sensor. This first-in-human clinical study is being conducted to validate the suprachoroidally placed Eyemate-SC, a sensor implant for continual monitoring of intraocular pressure (IOP).

While Implandata’s already CE-marked Eyemate-IO intraocular sensor implant is intended for use in glaucoma patients undergoing cataract surgery, the Eyemate-SC device allows implantation in glaucoma patients not indicated for cataract surgery yet, according to the Hanover, Germany company.

Get the full story on our sister site, Medical Design & Outsourcing.

The post ‘Breakthrough’ eye-pressure sensor trial begins in Germany appeared first on MassDevice.

FDA chooses 8 medtech companies for opioid crisis challenge

(Image from Unsplash.com)

The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis.

More than 250 companies submitted entries to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, announced in May. Those selected include Masimo Corp. and deep-brain-stimulation company Brainsway Ltd. The companies will be expected to produce devices intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide pain treatment alternatives to opioids.

(Source: FDA)

The selected firms will work closely with the agency on accelerated development and review of their products. The FDA said it will grant breakthrough device designation to those devices that meet the statutory criteria for the designation, without the companies having to submit a separate application.

Participating companies and the FDA will enter a 90-day collaboration to reach agreement on the device’s profile, including patient and user needs, risks and benefits,  and to discuss the potential regulatory pathways going forward. Applicants will eventually submit one or more formal applications to the FDA, which will expedite their review times. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies, according to the agency.

The roots of the prescription opioid overdose crisis in America go back to the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive but actually were. Medical professionals more frequently prescribed opioid painkillers, and opioid-related deaths steadily increased. Tens of thousands of people have been dying annually, according to the Centers for Disease Control and Prevention.

The FDA encouraged applicants who were not selected to interact with the agency through the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov. DICE will assist in answering questions on U.S. medical device regulation or to direct sponsors to the appropriate premarket review division.

The FDA in recent years has already cleared, granted or approved more than 200 devices to help treat or manage pain; 10 of them involved new or novel technologies including brain and spinal cord stimulators to relieve pain. FDA also recently granted a new indication to an electric stimulation device that could help reduce the symptoms of opioid withdrawal.

The post FDA chooses 8 medtech companies for opioid crisis challenge appeared first on MassDevice.

Medtronic studies use of both heat and cold for cardiac ablation

Medtronic logo updatedMedtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment.

The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic.

During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used both the Cardioblate irrigated RF system and the CryoFlex surgical ablation system. The surgical team used both Medtronic devices to make a pattern of lesions in the heart muscle in order to help it return to its normal rhythm.

“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” Damiano said in a news release.

“We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease,” said Damiano, who is the national principal investigator of the Terminate AF trial.

The study will involve up to 15 centers in the U.S. and up to 160 patients. Researchers will assess patients at one, three, six and 12 months; the primary efficacy endpoint is for patients to not have AF after the removal of antiarrhythmic drug therapy (three months post-procedure).

“An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation,” said John Mack, VP and general manager of Medtronic’s Cardiac Surgery business.

FDA cleared Cardioblate in 2000 and CryoFlex in 2004.

The post Medtronic studies use of both heat and cold for cardiac ablation appeared first on MassDevice.

Sonova licenses Ceva’s RivieraWaves Bluetooth tech for Sword 3.0 hearing aid chip

Sonova

Sonova Holding AG (SIX:SOON) has inked a deal to license Ceva’s RivieraWaves Bluetooth intellectual property for use in its Sword 3.0 wireless hearing aid chip, Ceva said today.

The licensed RivieraWaves Bluetooth IP platform consists of a hardware baseband controller and software protocol stack and will help power the Sword 3.0, which Sonova touts as the world’s first and only hearing aid radio chip that will fully support direct binaural streaming of audio content.

“We are delighted to formally announce our partnership with Sonova, for our RivieraWaves Bluetooth IP. It’s a testament to the quality of our Bluetooth technology for even the most stringent use cases and we look forward to continuing our work together as Bluetooth looks set to become the wireless standard of choice for hearing aids and other smart hearing devices,” CEVA connectivity biz GM Aviv Malinovitch said in a prepared statement.

The Sword 3.0 device is intended to connect to a smartphone for internet access that will allow the devices to be adjusted remotely by their hearing care professional, the companies said.

“Our latest generation Sword chip reinforces our mission to continually introduce new and innovative technologies that greatly improve the user experience of hearing aids. The integration of CEVA’s advanced Bluetooth Dual Mode IP into our wireless chip enables us to bring low power stereo audio streaming and data connectivity to our hearing aids, giving our customers an unparalleled user experience,” Sonova wireless R&D director Marc Secall said in a press release.

In August, Sonova subsidiary Advanced Bionics said that it won FDA approval for its HiRes Ultra 3D cochlear implant.

The post Sonova licenses Ceva’s RivieraWaves Bluetooth tech for Sword 3.0 hearing aid chip appeared first on MassDevice.

Google’s Verily spikes glucose-sensing lens project with Novartis’ Alcon

Verily, Novartis' Alcon

Google (NSDQ:GOOG) life sciences company Verily said late last week that it is putting its joint project with Novartis (NYSE:NVS) unit Alcon to develop a glucose-sensing contact lens on hold due to difficulties in obtaining reliable tear glucose readings.

The project, which began in 2014, aimed to develop a contact lens that could measure glucose levels for individuals living with diabetes, according to a blog post from Verily chief technical officer Brian Otis.

But measuring glucose levels from tear glucose has proven to be unreliable, according to the blog posting.

“Our clinical work on the glucose-sensing lens demonstrated that there was insufficient consistency in our measurements of the correlation between tear glucose and blood glucose concentrations to support the requirements of a medical device. In part, this was associated with the challenges of obtaining reliable tear glucose readings in the complex on-eye environment. For example, we found that interference from biomolecules in tears resulted in challenges in obtaining accurate glucose readings from the small quantities of glucose in the tear film. In addition, our clinical studies have demonstrated challenges in achieving the steady state conditions necessary for reliable tear glucose readings,” Otis wrote in the posting.

The companies are still jointly developing smart contact lens devices for a number of other uses, according to the posting. The teams have developed methods to integrate wireless electronics and sensors in “thousands of lenses in numerous form factors.”

Other projects the companies have added to the list include smart intraocular lenses intended to improve sight following cataract surgery and smart accommodating contact lens tech for treating presbyopia, Otis wrote.

Verily and Alcon will continue to partner on both the smart accommodating contact lens and smart intraocular lens projects.

“We’re looking forward to the next phase of development on our other two Smart Lens programs with Alcon, where we are applying all our significant technical learnings and achievements to prevalent conditions in ophtalmology,” Otis wrote in the blog posting.

The post Google’s Verily spikes glucose-sensing lens project with Novartis’ Alcon appeared first on MassDevice.