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DTW Podcast: Can AI, advanced imaging and robotics “democratize” surgery?

A new generation of digital surgery systems will level the playing field for surgeons giving them artificial intelligence, robotic tools and other assistive technologies.

In three interviews in this week’s DeviceTalks Weekly Podcast, leaders form Asensus, ActivSurgical and Memic explain how their systems will improve surgeon performance, reduce errors, and deliver the “democratization” of surgical robotics.

Guests this week include

Anthony Fernando, CEO of Asensus Surgical (formerly Transenterix), outlines the company’s bid to push its Sehance system as a solution for laparoscopic procedures. Fernando, who took over as CEO in 2019, explains why the company’s stock crashed in 2019 and details the changes that he says has started the company’s turnaround. Senhance offers more responsive surgical tools along with data that will help with surgical training and scheduling.

Todd Usen, CEO of ActivSurgical, left a job he loved at Olympus to lead a compan…

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Canada authorizes J&J’s COVID-19 vaccine

Photo by Hermes Rivera on Unsplash

Canada is hoping to accelerate its mass-vaccination program with the authorization of Johnson & Johnson’s COVID-19 vaccine, which the FDA also recently authorized.

Canada has now authorized four vaccines.

Pfizer has also agreed to ramp up deliveries to the country.

By the end of June, Canada could have 36.5 million vaccine doses. The country’s population is 37.9 million.

Ontario, the most densely populated province, also announced that it would allow the first and second doses of the Pfizer-BioNTech and Moderna vaccines to be administered with an up to four-month interval between doses.

The J&J vaccine currently requires only a single dose, although the company is testing a two-dose regimen.

Because the U.S. isn’t currently allowing domestically produced vaccines to be exported, Canada has relied on Europe and Asia to provide vacci…

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Study finds AstraZeneca COVID-19 vaccine could be effective against Brazil variant

Early data from a University of Oxford study indicates the COVID-19 vaccine it jointly developed with AstraZeneca is effective against the P.1 variant, which originated in Brazil. 

The study has not yet been published, but Reuters confirmed its results. 

South Africa recently paused the vaccine rollout, where a similar variant is circulating after early study data indicated the vaccine offers little to no protection against mild-to-moderate disease. 

That study found that the AstraZeneca ChAdOx1 nCoV-19 had an efficacy of 21.9% after 14 days of receiving the second dose of vaccine. The participants in that study were seronegative to the adenovirus used as a vector. 

The P.1 variant appears to resist immunity from natural infection, and a Lancet preprint suggested that the COVID-19 vaccine from China-based CoronaVac is not effective against the variant.  

Brazil has seen one of the longest-lived waves of COVID-19 infections, with more than 7…

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First OTC molecular test for COVID-19 gains FDA nod

The Cue Health molecular COVID test includes a nasal swab, test cartridge and cartridge reader for home use. (Image from Cue Health)

The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription.

The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils.

The authorized test includes a single-use Cue COVID-19 test cartridge, a single-use nasal swab and the Cue cartridge reader (used by the Cue Health monitoring system, provided separately). The reusable, battery-operated cartridge reader runs the Cue test cartridge and communicates results directly to the customer’s Cue Health smartphone app in about 20 minutes.

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

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Private equity firm GTCR forms Epselon Global to acquire healthcare businesses

GTCR announced that it entered into a Leaders Strategy partnership to form Epselon Global with a focus on acquiring healthcare businesses.

The private equity firm partnered with Michael Mulhern and Phil Macnabb to form the Chicago-based company centered around acquiring companies and assets as part of a strategy to build a market-leading healthcare business, according to a news release.

Leaders Strategy was pioneered by GTCR to find and partner with management leaders in core domains to identify, acquire and build market-leading companies.

Through the Leaders Strategy, GTCR will invest in Epselon from its GTCR Fund XIII, a private equity fund with $7.5 billion in limited partner capital commitments. Mulhern will serve as the executive chairman and Macnabb will hold the role of CEO, while each will make a substantial investment alongside GTCR.

“We are very excited to once again partner with Michael and Phil,” GTCR managing director Sean…

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Former Abbott sales director’s age discrimination suit can proceed

[Image from Unsplash]A New Jersey federal judge has ruled that an age bias lawsuit from a former sales director at Abbott (NYSE:ABT) can move forward.

Richard Rudolph alleged that, after 15 years as a sales director at the Abbott Park, Ill.-based medtech company, he was let go because of his age at 55 years old.

Rudolph claimed that the company laid out unreasonable performance goals to create an opportunity to force him out. Targets referred to by Rudolph — and whether he achieved them — are subject to dispute between him and his supervisor at Abbott, U.S. District Judge Peter G. Sheridan wrote in his order denying Abbott’s motion for summary judgment.

Abbott required Rudolph to achieve specific sales performance requirements each month in three regions, make three 30-day sales forecasts with more than 90% accuracy, deliver 100% accurate and current data at the end of each month and grow distribution partner McKesson’s ambulatory…

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Second Sight gains FDA nod for retinal system that may never be produced

Second Sight Medical  (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal prosthesis system, but questions remain about whether it will ever be manufactured.

Second Sight announced in March 2020 that it would wind down its operations amid the financial shock of the coronavirus pandemic. In April, the company said it took steps to reduce overhead and conserve liquidity ahead of potential partnering, acquiring, or combining with businesses, just days before pricing a $6.8 million offering of its common stock, which closed in May. An auction of its assets was set for June, and Second Sight announced a merger with Pixium Vision in January.

If the merger closes, Pixium — which makes neuromodulation tech to treat blindness — would become the controlling shareholder, owning 60% of the total equity before a capital raise. The combined company would focus on Pixium’s Prima retinal stimulation system and create a new subsidiary to focus on …

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COVID-19 vaccine hesitancy reducing, but challenges remain

Image courtesy of Pexels

The likely timeline for vaccinating a large share of the U.S. public has tightened recently. On Tuesday, President Biden promised enough COVID-19 vaccine would be available for all Americans by the end of May. 

But while increases in vaccine production can address the current vaccine shortage, vaccine hesitancy will likely curb vaccination efforts in the coming months, according to Philipp Rosenbaum, a senior healthcare analyst at GlobalData. “With increases in vaccine production from Pfizer/BioNTech and Moderna, a newly authorized vaccine from Johnson and Johnson, and a manufacturing partnership between J&J and Merck & Co., confidence in reaching the goal is high.” 

Indeed, the proportion of the public intending to receive the vaccine has increased from 60% to 69%, according to data from the Pew Research Center.

But many Americans don’t want the vaccine. Almost…

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Abbott wins EUA for COVID-19, flu, RSV combo assay

Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay.

The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is available in other countries outside the U.S., according to a news release.

Abbott Park, Ill.-based Abbott’s Alinity m Resp-4-Plex test uses one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or self-collected at a healthcare location. The test will run on Abbott’s Alinity m system using PCR technology.

The company said that, along with providing diagnostic results for four separate viruses, offering flexibility and efficiency, it will also ease the resource strain on collection devices that remain in high demand amid the COVID-19 pandemic. Read more

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Colfax to split to create new orthopedic device giant

Colfax (NYSE:CFX) plans to split into two publicly traded companies early next year — with businesses including DJO forming a new stand-alone orthopedic device company.

The split — announced yesterday — will create a to-be-named medical device company headquartered in Wilmington, Del., with a significant presence in Dallas. Present Colfax CEO Matt Trerotol will lead the medtech business, with Colfax EVP Brady Shirley serving as COO. Present Colfax EVP Shyam Kambeyanda will lead the other company — called ESAB — focusing on fabrication technology and operating out of Colfax’s present Annapolis Junction, Md. headquarters.

Colfax’s Medical Technology operating segment is expected to bring in $1.4 billion this year. When it becomes a stand-alone company in Q1 2022, it will likely be either the sixth or seventh largest orthopedic device company in the world. Its ranking will depend on the size of Zimmer Biomet’s planned spine and dental business sp…

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Iridex, Topcon seal eye care deal

Iridex (NSDQ:IRIX) announced that it entered into a strategic collaboration with Topcon to develop glaucoma therapy products.

Mountain View, Calif.-based Iridex said in a news release that the transaction brings in $19.5 million in cash to the company, providing multiyear funding for strategic growth initiatives, namely those seeking to penetrate the market with Iridex’s non-incisional glaucoma therapy products.

Topcon is set to purchase $10 million of Iridex’s common shares at $6.18 per share.

Additionally, Japan-based Topcon — which brings in $1.3 billion in revenues with $430 million coming from its eye care business — will invest in Iridex by purchasing the exculsive rights to distribute its retina and glaucoma products in certain global markets while also acquiring a common equity stake in approximately 10.4% of Iridex.

Iridex’s product portfolio is set to benfit from Topcon’s distribution capabilities in the Asia Paci…

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SmileDirectClub dips on missed Q4 projections

SmileDirectClub (NSDQ:SDC) shares dipped during pre-market trading today on fourth-quarter results that missed the consensus forecast.

The Nashville, Tenn.-based company posted losses of -$32.9 million, or -9¢ per share, on sales of $172.6 million for the three months ended Dec. 31, 2020, for a 66.1% bottom-line gain on a sales decline of -6.2%.

SmileDirectClub’s EPS of 9¢ came in 1¢ behind projections on Wall Street, where analysts were looking for sales of $181.1 million.

“Despite the swift onset of the pandemic and the macro uncertainty throughout 2020, our performance throughout the year was continued validation of the strength of our business model, and the power of the competitive moats around our platform. It also demonstrated our ability to deliver on our continued focus of controlled growth with profitability. We outlined this strategy in Q4 of 2019, and we have been executing against it in the four quarters since,” SmileDirectClub CEO …
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MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon

MedAlliance this week said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter.

Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with atherosclerotic lesions.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Medtronic launches DCB for dialysis patients in Japan

Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis.

The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal disease and undergoing hemodialysis. It is the first drug-coated balloon to be approved in Japan for that vessel bed, according to Medtronic.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Acuitive Technologies gains FDA nod for ligament reconstruction devices

Acuitive Technologies this week announced that it received FDA 510(k) clearance for its Citrespline and Citrelock ligament reconstruction devices.

The two systems are designed to firmly engage tendons and ligaments with a bone tunnel while preserving the integrity of the soft tissue during insertion of the device, according to the company. Citrespline and Citrelock are intended for use in orthopedic surgeries for the fixation of ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle and foot.

“This FDA clearance for the Citrespline and Citrelock system is a significant milestone that allows Acuitive to compete in the sports medicine market using innovative materials and designs that protect the soft tissue during insertion while improving fixation strength,” Acuitive Technologies managing partner Michael McCarthy said in a news release. “The Citrespline/Citrelock System is the third innovation from our robust pipeli…

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Alphatec posts mixed-bag Q4 results

Alphatec (NSDQ:ATEC) posted fourth-quarter results that beat the revenue consensus on Wall Street but missed on earnings.

The Carlsbad, Calif.-based company reported losses of -$26.8 million, or -35¢ per share, on sales of $43.9 million for the three months ended Dec. 31, 2020, for a sales growth of 35.9% compared with Q4 2019.

Earnings per share were -35¢, 15¢ behind The Street, where analysts were looking for sales of $43.88 million and -20¢ per share.

“It’s no accident that ATEC has averaged nearly 30% revenue growth over the past eight quarters,” CEO Pat Miles said in a news release. “We are committed to the intentional, methodical task of compelling surgeon adoption through clinical distinction and to evolving our increasingly exclusive sales footprint. We will continue expanding market share by remaining focused on the priorities that got us here. I am confident that the clinical prowess and relentless determination of our team, coupled with our ex…

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Senseonics sinks on mixed bag Q4, massive bottom-line slide

Senseonics (NYSE:SENS) shares took a hit today on fourth-quarter losses that missed the consensus earnings forecast.

SENS shares were hit hard at market close yesterday after financial results were released, dipping -15.7% to $2.69 per share. In pre-market trading this morning, they are down -7.8% at $2.48 per share.

The Germantown, Md.-based implantable continuous glucose monitor maker posted losses of -$101.6 million, or -41¢ per share, on sales of $3.9 million for the three months ended Dec. 31, 2020, for a massive bottom-line slide from losses of -$35.6 million this time a year ago on a sales decline of -56.7%.

Get the full story at our sister site, Drug Delivery Business News.

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Asensus finalizes name change from TransEnterix, debuts NYSE ticker

Asensus Surgical (NYSE:ASXC) announced today that it formally completed its name and stock ticker change from TransEnterix (NYSE:TRXC).

Research Park Triangle, N.C.-based Asensus announced last month that the company would change its name from TransEnterix to Asensus Surgical and introduce a new surgery category. The company aims to enter a new era of performance-guided surgery focused on digitizing the interface between surgeons and patients to bring clinical intelligence that may enable better outcomes and, potentially, a new standard of surgery.

Effective today, the company’s stock is trading on the New York Stock Exchange American under the ASXC ticker. No actions are needed from current stockholders relative to the change. Shares of ASXC are currently trading at $4.08 per share, having closed yesterday down -10.1%.

Just this week, Asensus garnered its first regulatory nod since the name change, winning expanded FDA clearance for general surger…

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Organ-chips could streamline drug development, but hurdles remain

Emulate Bio’s CHIP-S1

While organ-on-a-chip technology has evolved tremendously over the past 15 years, adoption of the technology remains at an early stage. But as organ-chip technology advances and the R&D costs for pharma companies continue to hover near unsustainable levels, organ-on-a-chip technology has the promise to address what cell biologist and bioengineer Donald Ingber called the “broken” drug-development model. 

One of the key challenges is the drug industry’s reliance on animal studies in preclinical research, Ingber said in an Emulate Bio virtual event. “There are ethical issues,” said Ingber, a member of the company’s board of directors. “But the real problem is that the results of these animal preclinical models often don’t predict clinical responses,” he added. 

Get the full story from our sister site, Drug Discovery & Development. 

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Ivermectin not supported for mild COVID-19, study says

Ivermectin image courtesy of Wikipedia.

The antiparasitic drug ivermectin does not appear to be an efficacious COVID-19 treatment for mild COVID-19 cases, based on a randomized study recently published in JAMA.

Ivermectin — which is widely used in veterinary medicine to get rid of worms and other parasites— emerged as a potential COVID-19 treatment, owing to its ability to inhibit replication of the SARS-CoV-2 drugin in vitro and animal studies. 

Similar research elevated hydroxychloroquine as a potential COVID-19 therapeutic agent, but the drug also has disappointed in human studies. The World Health Organization now cautions against its use as a COVID-19 treatment. 

Get the full story from our sister site, Drug Discovery & Development. 

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RCSB Protein Data Bank now has more than 1,000 SARS-CoV-2 proteins

Acknowledgement: Illustration by David S. Goodsell, RCSB Protein Data Bank; doi: 10.2210/rcsb_pdb/goodsell-gallery-026

The RCSB Protein Data Bank has announced that more than 1,000 SARS-CoV-2 proteins are available at no cost. 

Headquartered at Rutgers University–New Brunswick, the RCSB Protein Data Bank released its first SARS-CoV-2 structure — the coronavirus main protease (PDB 6lu7) — on Feb. 5, 2020. 

The database has helped drive the development of effective COVID-19 vaccines. It continues to shed light on emerging variants of the virus, according to Stephen K. Burley, director of the RCSB Protein Data Bank. “The impact of structural biologists on research related to COVID-19 is a testament to the power of the experimental tools they use and their commitment to making data open access for the public good,” Burley said in a statement.

The database also offers proteins related to other viral…

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