North America

Spinal market shows backbone for growth at NASS

Fri, 20 Oct 2023 12:00:00 -0400

The North American Spine Society Annual Meeting provided a positive view of one area in orthopedics that may be immune from the effects of widespread use of GLP-1 medications. Recent data indicates volumes and seasonality have finally recovered from pandemic impacts. Major trends discussed at the conference included expanded use of robotic systems, increased customization and adoption of augmented reality technology.

Recruitment underway for clinical study of PBM for treating long COVID-19

Mon, 21 Aug 2023 12:00:00 -0400

Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body.

Venus Concept undertakes strategic facelift

Tue, 07 Feb 2023 13:00:00 -0500

Venus Concept Inc. is undergoing a bit of nip and tuck in efforts to improve the company’s cash flow position and obtain long-term stability. As part of the reconfiguration, the company plans to shed 18% of its workforce with layoffs starting on Feb. 6. In Israel and North America. The executive leadership team also experienced some plumping and extraction.

Calling San Diego: 858 Therapeutics closes $60M series A round to drug RNA modulation

Tue, 21 Sep 2021 13:00:00 -0400

858 Therapeutics Inc. emerged from stealth mode, unveiling $60 million in series A funding and plans to drug a series of protein targets involved in modulating RNA biology in cancer.

Tired of waiting for vaccines, PAHO proposes making its own

Thu, 26 Aug 2021 12:00:00 -0400

With the Americas having the dubious distinction of the most COVID-19 cases in the world, the Pan American Health Organization (PAHO) is answering that “wake-up call” with plans to develop a collaborative platform to develop mRNA vaccine production in Latin America and the Caribbean.

Business as usual: Versant raises $950M for three new funds

Wed, 21 Apr 2021 12:00:00 -0400

Versant Ventures has closed three new funds with an aggregate raise of $950 million to allocate to the next wave of innovative startups across North America and Europe. The money is new, but everything else is more or less unchanged. “It’s the same strategy, same team, same geography, same operational model,” Versant chairman and managing director Brad Bolzon told BioWorld.

Boston Scientific gets green light for Ranger DC

Mon, 02 Nov 2020 12:00:00 -0500

Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.

FDA clears first brain stimulation device for smoking cessation

Wed, 26 Aug 2020 13:00:00 -0400

The U.S. FDA has given the green light to a new type of treatment to help smokers quit, clearing the way for the first time the use of deep transcranial magnetic stimulation (Deep TMS) for short-term smoking cessation in adults.

Mexican team led by vets racing to develop COVID-19 vaccine

Thu, 07 May 2020 12:00:00 -0400

CAJICA, Colombia – A research team at the Autonomous University of Queretaro (UAQ), Mexico, is working to develop a COVID-19 vaccine, joining about 100 other teams working toward a similar goal. Unlike other teams, however, this one is being led by veterinarians.

COVID-19 spreading but not yet pandemic disease, says WHO

Tue, 25 Feb 2020 14:07:00 -0500

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea. Parts of northern Italy are in lockdown, with 200-plus cases and seven deaths. Austria and Switzerland are reported to be considering closing their borders with Italy, and the EU has responded with a €232 million (US$252 million) package of aid, including €90 million for development of a vaccine and €10 million for therapeutics and diagnostics.

COVID-19 spreading but not yet pandemic disease, says WHO

Mon, 24 Feb 2020 12:00:00 -0500

Investors stuck on Cohesys adhesive bone tape for use in facial reconstruction

Wed, 16 Oct 2019 00:00:00 -0400

TORONTO – A total of $1.4 million in capital funding from 12 U.S., Canadian and European angel investors will help Toronto-based Cohesys Inc. complete preclinical animal studies, with an eye toward gaining approval for its nontoxic, adhesive tape for rebuilding facial bones.

Courts split on DoJ authority to dismiss False Claims Act cases

Wed, 16 Oct 2019 00:00:00 -0400

The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.

Medtronic scores breakthrough device designation for TAAA stent graft system

Wed, 09 Oct 2019 00:00:00 -0400

Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).

Pq Bypass gets FDA OK to launch Torus SFA stent graft pivotal trial

Wed, 09 Oct 2019 00:00:00 -0400

The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.

Cybersecurity may be next front in False Claims Act litigation

Tue, 08 Oct 2019 00:00:00 -0400

The device industry is quite familiar with whistleblower lawsuits, but Cisco Systems Inc., of San Jose, Calif., was recently forced to pay more than $8 million in connection with a qui tam lawsuit over cybersecurity lapses for video surveillance equipment sold to state and federal government agencies. The case suggests device makers will have to be up to speed on cybersecurity if they wish to avoid suffering a similar fate, particularly given a recent warning the FDA posted regarding a widespread cybersecurity vulnerability.

Politics overriding congressional Rx pricing fix

Thu, 26 Sep 2019 00:00:00 -0400

Wednesday's House subcommittee hearing on H.R. 3, which tasks Medicare with directly negotiating prescription drug prices in the U.S., may have been an exercise in futility. Although both Republicans and Democrats in Congress still agree that something has to be done to lower drug prices, they are beyond compromise on key aspects of H.R. 3, the Lower Drug Costs Now Act.

Prescient Metabiomics granted breakthrough status for noninvasive colorectal cancer test

Mon, 16 Sep 2019 00:00:00 -0400

The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.