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Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

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

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Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

The software upgrades for Servo-u and Servo-n include the automatic stepwise recruitment maneuver, a standardized and automated workflow designed to guide lung recruitment and help clinicians identify a personalized PEEP that provides the lowest driving pressure.

Additionally, the upgrades offer stress index and transpulmonary pressure monitoring, including key parameters for the assessment of lung stress during controlled and spontaneous ventilation, which compliments the lung-protective toolkit that divid…

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The 10 largest orthopedic device companies in the world

[Image from Pixaby]Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

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The 10 largest orthopedic device companies in the world

[Image from Pixaby]

Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the w…

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Titan Medical expands senior leadership team

Titan Medical (TSX:TMD;OTC:TITFX) announced today that it appointed two new members to its senior leadership team.

Kristen Galfetti will join as VP of investor relations & corporate communications and will be located in Boston, while Chien Huang as been appointed as VP of finance and will be located in Toronto.

Galfetti, a more than 20-year veteran of leading investor relations and corporate communications programs, most recently provided consulting services to small and medium companies in the life science industries, according to a news release.

In addition to her consulting, Galfetti has served as VP of investor relations & corporate communications at Cynapsus Therapeutics. Before that, she held the role of senior director of investor relations at Sanofi. Other companies Galfetti has worked at include AMAG Pharmaceuticals and Genzyme Corporation.

Huang has spent more than 20 years working with the development and implementation of finan…

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Delpor doses first patient in once-yearly risperidone implant trial

The DLP-114 implant [image from Delpor]Delpor announced today that it dosed the first patient in a Phase 1b/2a clinical trial for its DLP-114 risperidone implant.

DLP-114 is a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. The open-label study is to evaluate the safety, tolerability and pharmacokinetics of switching from oral risperidone to the once- or twice-yearly DLP-114 risperidone implant, according to a news release.

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

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Red One Medical, Quick Tube Medical partner to deliver chest tubes to U.S. military

Red One Medical and Quick Tube Medical this week announced a partnership to provide chest tube devices to U.S. military members.

Quick Tube Medical’s chest tube system has a rapid deployment system for an average insertion to completion time of 30 to 45 seconds compared to eight minutes for some traditional chest tubes.

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

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Ambu nabs Health Canada clearance for single-use cystoscope

Ambu (CPH:AMBU-B) today said it received Health Canada clearance for its aScope 4 Cysto single-use cystoscope.

The cystoscope is a flexible, single-use endoscope that is designed to eliminate significant capital, repair and cleaning costs with a patient-ready instrument for every procedure, according to Ambu. The device is used for diagnosing, managing and treating lower urinary disorders such as hematuria, incontinence and bladder cancer.

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

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Ambu nabs Health Canada clearance for single-use cystoscope

Ambu today said it received Health Canada clearance for its aScope 4 Cysto single-use cystoscope.

The cystoscope is a flexible, single-use endoscope that is designed to eliminate significant capital, repair and cleaning costs with a patient-ready instrument for every procedure, according to Ambu. The device is used for diagnosing, managing and treating lower urinary disorders such as hematuria, incontinence and bladder cancer.

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

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Orthofix wins FDA clearance for 3D printed TLIF spacer system

Orthofix (NSDQ:OFIX) today said it received FDA 510(k) clearance for its Forza Ti TLIF spacer system.

The Forza Ti spacer is designed to optimize transforaminal lumbar interbody fusion (TLIF) procedures, according to the company. It has a titanium 3D-printed interbody with porosity and surface that allows bones to grow into and through the spacer.

Interbody implants are typically inserted between the vertebrae during a spinal fusion surgery to help relieve pressure on nerves and to hold the vertebrae in place while fusion occurs.

“The 3D-printed surface technology, titanium material, and implant design all play a role in the bone growth process during fusion,” Gary Rosenberg, an orthopedic spine surgeon operating at Orange County Global Medical Center in Santa Ana, Calif. who performed the first Forza Ti TLIF spacer patient implant procedure, said in a news release. “The intuitive instrumentation allows for easy insertion, and the optimized porosity and …

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DarioHealth partners with MediOrbis on virtual diabetes care platform

DarioHealth (NSDQ:DRIO) announced that it launched a new virtual care initiative with MediOrbis to improve virtual care for diabetes.

New York-based DarioHealth’s collaboration with MediOrbis is slated to offer eligible Medicare members with diabetes a convenient method for virtual care that includes MediOrbis’ telehealth offerings and DarioHealth’s AI-powered remote patient monitoring, according to a news release.

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

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Danaher ticks up on Street-beating Q1

Danaher (NYSE:DHR) shares rose before hours on first-quarter results that easily toppled the consensus forecast.

The Washington, D.C.-based company posted profits of $1.7 billion, or $2.29 per share, on sales of $6.9 billion for the three months ended April 2, 2021, nearly tripling its bottom-line on sales growth of 57.9%.

Adjusted to exclude one-time items, earnings per share were $2.52, 77¢ ahead of Wall Street, where analysts were looking for sales of $6.3 billion.

“We had a very strong start to the year, delivering better-than-expected first-quarter results across our portfolio,” Danaher president & CEO Rainer M. Blair said in a news release. “This broad-based outperformance was driven by double-digit core revenue growth in our base business, and our ongoing contributions to the development and production of COVID-19 vaccines, therapeutics and diagnostic tests.

“Our record top-line performance contributed to strong earnin…

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Glaukos inks licensing deal with Intratus for Eyelid drug delivery platform

Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Intratus over its Eyelid drug delivery platform.

San Clemente, Calif.-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Intratus’ patented, non-invasive Eyelid drug delivery platform for treating presbyopia, according to a news release. Financial terms were not disclosed.

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

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Roche retools COVID-19 strategy 

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have complicated recruitment. 

“There’s just simply not enough patients to enroll with the speed we were hoping for,” said Bill Anderson, head of Roche’s pharmaceutical division, in a conference call. 

Roche and Atea hoped AT-527 would offer a more convenient alternative to intravenous treatments such as antibody cocktails or Gilead Science’s (NSDQ:GILD) remdesivir.

One of the two canceled Phase 2 studies was for the monoclonal antibody astegolimab (RG6149), which the company had licensed from Amgen (NSDQ:AMGN). 

The other Phase 2 trial Roche halted related to RG7880 (efmarodocokin alfa), which the company hoped…

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FDA loses ‘drug or device’ argument again

Drug or device? Genus Medical Technologies says it’s a device. (Image from Genus Medical Technologies)

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug.

The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.

Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does.

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

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FDA loses ‘drug or device’ argument again

Drug or device? Genus Medical Technologies says it’s a device. (Image from Genus Medical Technologies)

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug.

The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.

Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does.

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

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Novo Nordisk to test oral semaglutide as an obesity therapy

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity. 

The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events. 

The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities. 

The company anticipates that the 68-week study will kick off in the second half of 2021. 

Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss. 

Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…

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FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent Biosolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

Get the full story from our sister site, Pharmaceutical Processing World. 

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FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

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Philips’ trade secret suit against Chinese companies can proceed

A federal judge has ruled that two companies in China and a U.S. company must face a trade secrets lawsuit by Philips.

Philips claims that two former employees who joined GL Leading, an Aurora, Ill.-based firm allegedly formed from a pair of related companies in China, stole proprietary information about certain Philips’ X-ray tubes. Philips is also suing those former employees, Jose Buan and  Sherman Jen, as well as the Chinese companies, Kunshan Yiyuan Medical Technology and Kunshan Guoli Electronic Technology,

Philips alleges that in late December 2017, Buan copied more than 800 of Philips’ files, “including trade secret and other confidential business information” onto portable drives, according to the order by Judge Marvin E. Aspen.

“A subsequent investigation revealed that Buan took ‘a trove’ of additional files containing ‘confidential and trade secret technical and business information pertaining to the 2XXX series X…

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UC Berkeley researchers tout tiny sensor that can detect tissue oxygen levels

Engineers at the University of California, Berkeley, are touting an implant that can provide real-time measurements of tissue oxygen levels.

The tiny wireless device is smaller than a ladybug and powered by ultrasound waves to help monitor the health of transplanted organs or tissue through real-time measurements of oxygen levels in tissues deep beneath the skin, according to a news release.

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

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