Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document. Are you hiring?

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

FDA 52

FDA Food and Drug Administration Transportation Recruitment 52

Legacy MEDSearch

DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

Legacy MEDSearch

MARCH 2, 2023

Apyx Medical Corporation (NASDAQ:APYX) , the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion ® , today announced it has received 510(k) clearance from the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space. Are you hiring?

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

MAY 30, 2023

Food and Drug Administration (FDA). It’s been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success,” said Duncan Smith, managing partner of Sagentia Innovation. THINK Surgical, Inc., About THINK Surgical, Inc. THINK Surgical, Inc.,

FDA 52

FDA Food and Drug Administration Recruitment Consulting 52

Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The novel Reverse HRS is now beginning enrollment in the FDA IDE clinical trial with multiple outcome measures being evaluated.” Press Release by: Hip Innovation Technology. Are you hiring?

FDA 98

FDA Safety Recruitment Patients 98

European Pharmaceutical Review

MAY 22, 2024

WHO confirmed that the newly approved WLAs include: The European Medicines Regulatory Network (EMRN), which is made up of the European Commission (EC), the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 countries.

Medicine 67

Medicine Leads Food and Drug Administration Safety 67

pharmaphorum

JUNE 22, 2022

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap.

Pharma 111

Pharma Manufacturing Government FDA 111

Legacy MEDSearch

JULY 14, 2023

In addition, AceConnex Pre-Sutured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured pre-operatively. “We are proud to be first to market with an FDA cleared pre-sutured fascia device to meet the varying needs of hip arthroscopists and patients.”

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

DECEMBER 16, 2022

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Manufacturing 52

Legacy MEDSearch

AUGUST 14, 2023

Kerecis is the only approved manufacturer of medical devices containing intact fish skin globally. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. Are you hiring?

FDA 52

FDA Recruitment Medical Doctors 52

Legacy MEDSearch

OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

FDA 52

FDA Food and Drug Administration Recruitment Manufacturing 52

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 17 and 21, COMANECI , and COLUMBUS /DRIVEWIRE are CE marked and FDA cleared.

Medical 52

Medical FDA Recruitment Physicians 52

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. For more information, visit [link].

Marketing 52

Marketing FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

MAY 18, 2023

“This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability. We invest in early-stage companies reinventing human augmentation, energy, transportation, infrastructure, manufacturing, and agriculture.

Medical 52

Medical FDA Food and Drug Administration Recruitment 52

pharmaphorum

OCTOBER 12, 2022

By remaining compliant, medicines are manufactured in line with their pre-defined and approved specifications, in order to ensure the delivery of safe and effective products to consumers. So, with mandates in place, how do manufacturing facilities meet these compliance goals? Cybersecurity and non-conformance.

Manufacturing 103

Manufacturing Medicine Leads Distribution 103

Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The post restor3d Receives FDA Clearance of Patient Specific Resection Guides for use with the Kinos Axiom Total Ankle System appeared first on Legacy MedSearch | Medical Device Recruiters.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Long production times and high energy costs in manufacturing are additional considerations.

Food and Drug Administration 77

Food and Drug Administration Manufacturing Safety Transportation 77

Legacy MEDSearch

SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment. OpSens Inc. ,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. From the manufacturer perspective, payer policies and legislation on combination therapy pricing are impacting global development, pricing, access, and commercialization strategies. Between May 1, 2016, and May 31, 2021, 42% of all U.S.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

Legacy MEDSearch

OCTOBER 14, 2022

a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous titanium cervical interbody device. ulrich medical USA, Inc., “Surgeons have many options for cervical interbodies.

Medical 95

Medical Recruitment Manufacturing Management 95

Pharmaceutical Technology

JULY 21, 2022

Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. While large pharma companies have been slow in this area, Merck and GSK are now using 3D printing for clinical trials and manufacturing.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

PM360

SEPTEMBER 21, 2023

Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. The 505(b)(2) New Drug Application process is a streamlined approval pathway for manufacturers to submit new drug applications. In 2024, ARPA removes the 100% AMP cap.

Management 105

Management Manufacturing Sales Competition 105

PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Legacy MEDSearch

APRIL 14, 2023

Northwell Holdings, the venture investment arm of Northwell Health, Topspin Fund, and Long Island Angel Network also participated in the round. This funding will be used by Neuvotion to further expand its team, complete clinical studies, and obtain FDA clearance for its initial product. ” About Neuvotion, Inc.

Engineering 52

Engineering Networking Recruitment Medical 52

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Medicine Pharma 97

Legacy MEDSearch

APRIL 3, 2023

ExtriCARE USA, is pleased to announce that its innovative extriCARE 3000 pump has received FDA approval for use in the United States. “We are thrilled to receive FDA approval for the extriCARE 3000 pump,” said Peter Mason , President of extriCARE USA.

Marketing 52

Marketing Recruitment Medical Distribution 52

MedTechVets

JULY 20, 2023

“ “Sometimes you may find that once you separate from the military that you miss the network, the camaraderie, the routine, and you may even find that you you’ve lost your sense of identity or purpose. It is also important to be willing and able to open and share your network.” Firstly, you must be humble.

Networking 52

Networking Medical Insurance Specialization 52

Medico Reach

JULY 3, 2022

Begin Preparation Before FDA Approval. Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. The launch date may be closer than you believe with the FDA’s unpredictable timeframe. Complete product documentation and make it easily accessible.

Medical 97

Medical Food and Drug Administration Training Marketing 97

Legacy MEDSearch

JULY 10, 2023

” The FDA approved the 50 mL Hizentra prefilled syringe in April 2023. About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world. KORU Medical Systems, Inc.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

Legacy MEDSearch

FEBRUARY 2, 2023

About Tyber Medical LLC Tyber Medical LLC, is a leading orthopedic medical device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-enhancing, regulatory-approved orthopedic implants for the spinal, extremity, and trauma markets.

Medical 98

Medical Recruitment Marketing Distribution 98

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. J National Comprehensive Cancer Network. To advance equity in clinical research, the U.S. However, another study found that 0.1%

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Rep-Lite

MAY 10, 2024

In recent years, shifts in healthcare regulations, including updates in FDA guidelines and compliance standards, have significantly impacted sales representatives and healthcare providers alike. Among these changes, updates in FDA guidelines and compliance standards are particularly significant for sales professionals.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

Legacy MEDSearch

NOVEMBER 6, 2023

HistoSonics, ( www.histosonics.com ), the manufacturer of the non-invasive Edison® Histotripsy System and novel sonic beam therapy, announced today that the Centers of Medicare & Medicaid Services (CMS) set a new payment rate for histotripsy of liver tumors procedures, increasing the payment rate to $17,500.

Recruitment 52

Recruitment Physicians Medical Patients 52